Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-18 @ 12:26 PM
Study NCT ID:
NCT03904693
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2019-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}, {'id': 'C533860', 'term': 'macitentan'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Clinical Scientific Leader', 'organization': 'Actelion Pharmaceuticals Ltd.'}, 'certainAgreement': {'otherDetails': 'Any study-related publication written independently by investigators must be submitted to the sponsor for review at least 30 days prior to submission for publication or presentation at a congress. Upon review, the sponsor may provide comments, and may also request alterations and/or deletions for the sole purpose of protecting its confidential information and/or patent rights. Neither the institution nor the investigator should permit publication during such a review period.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)', 'description': 'All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.', 'eventGroups': [{'id': 'EG000', 'title': 'DB: Treatment-naive and Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)', 'description': 'During double-blind (DB) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 16, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'DB: Treatment-naive And Prior ERA Strata: M/T FDC', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 71, 'otherNumAffected': 49, 'seriousNumAtRisk': 70, 'deathsNumAffected': 2, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 31, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 87, 'otherNumAffected': 58, 'seriousNumAtRisk': 86, 'deathsNumAffected': 2, 'seriousNumAffected': 12}, {'id': 'EG004', 'title': 'DB: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 108, 'otherNumAffected': 72, 'seriousNumAtRisk': 107, 'deathsNumAffected': 3, 'seriousNumAffected': 15}, {'id': 'EG005', 'title': 'OL: Treatment-naive and Prior ERA Strata: M/T FDC', 'description': 'After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA and received macitentan monotherapy during DB phase entered open label (OL) phase. During the OL phase participants received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching tadalafil 20 mg, orally, once daily for first 7 days (Week 17, titration phase). Subsequently participants received two tablets of tadalafil 20 mg along with one tablet of macitentan 10 mg, orally, once daily for 7 days (Week 18, titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 28, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG006', 'title': 'OL: Treatment-naive and Prior PDE-5i Strata: M/T FDC', 'description': 'After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of PDE-5i and received tadalafil monotherapy during DB phase entered OL phase. During the OL phase participants received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for the first 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 38, 'seriousNumAtRisk': 43, 'deathsNumAffected': 2, 'seriousNumAffected': 13}, {'id': 'EG007', 'title': 'DB + OL: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i, received macitentan 10 mg along with tadalafil 20 mg and placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily. After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i and received M/T FDC during DB phase entered OL phase. During the OL phase participants received one tablet macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 89, 'seriousNumAtRisk': 107, 'deathsNumAffected': 9, 'seriousNumAffected': 39}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Peripheral Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Suspected Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Blood Glucose Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Haemoglobin Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Normochromic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cor Pulmonale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Left Ventricular Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Right Ventricular Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Sinus Node Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Retinal Vein Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Colitis Ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Haemorrhoidal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hiatus Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Large Intestine Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Oesophageal Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Tongue Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Upper Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Varices Oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Peripheral Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Swelling Face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hepatic Cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Portal Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Abscess Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Covid-19 Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Gastroenteritis Clostridial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Parainfluenzae Virus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pneumonia Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Rhinovirus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Staphylococcal Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Femur Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Jaw Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Patella Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Subdural Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Greater Trochanteric Pain Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Systemic Scleroderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Mucinous Cystadenocarcinoma Ovary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': "Horner's Syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Glomerulonephritis Membranous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Renal Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Endometrial Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Intermenstrual Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Ovarian Cyst Ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Uterine Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Autoimmune Lung Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pulmonary Arterial Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pulmonary Veno-Occlusive Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pulmonary Vascular Resistance (PVR) Expressed as the Ratio of Geometric Means of End of Double-blind Treatment (EDBT) to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Treatment-naive And Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)', 'description': 'During double-blind (BD) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}, {'id': 'OG001', 'title': 'DB: Treatment-naive And Prior ERA Strata: M/T FDC', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}, {'id': 'OG002', 'title': 'DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.'}, {'id': 'OG003', 'title': 'DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.87'}, {'value': '0.55', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '0.60'}, {'value': '0.78', 'groupId': 'OG002', 'lowerLimit': '0.72', 'upperLimit': '0.84'}, {'value': '0.56', 'groupId': 'OG003', 'lowerLimit': '0.52', 'upperLimit': '0.60'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.82', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.80', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, EDBT (up to 16 weeks)', 'description': 'Change in PVR expressed as the ratio of geometric means of EDBT to baseline were reported.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all randomized participants who received at least one dose of study treatment (for participants on FDC, at least one dose of either macitentan or tadalafil). Treatment-naive participants randomized to both M/T FDC arms (ERA and PDE-5i strata) are counted twice as per planned analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to EDBT in 6-minutes Walking Distance (6MWD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Treatment-naive And Prior ERA Strata: Macitentan 10 Milligrams (mg)', 'description': 'During double-blind treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}, {'id': 'OG001', 'title': 'DB: Treatment-naive And Prior ERA Strata: M/T FDC', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}, {'id': 'OG002', 'title': 'DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.'}, {'id': 'OG003', 'title': 'DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC', 'description': 'During double-blind treatment period, participants who were either treatment-naive or on a predefined stable dose of PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '70.42', 'groupId': 'OG000'}, {'value': '52.9', 'spread': '88.23', 'groupId': 'OG001'}, {'value': '15.9', 'spread': '45.04', 'groupId': 'OG002'}, {'value': '43.4', 'spread': '78.03', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '=0.3802', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.04', 'ciLowerLimit': '-17.0', 'ciUpperLimit': '49.08', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.0591', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.37', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '51.59', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EDBT (Week 16)', 'description': 'Change from baseline to EDBT in 6MWD were reported. 6MWD was measured by 6-minute walk test (6MWT). The test measured the distance an individual was able to walk over a total of six minutes on a hard, flat surface with no obstacles. The goal was for the individual to walk as far as possible in 6 minutes.', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least one dose of study treatment (for participants on FDC, at least one dose of either macitentan or tadalafil). Treatment-naive participants randomized to both macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC) arms (ERA and PDE-5i strata) are counted twice as per planned analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT) in Cardiopulmonary Symptom Domain Scores to EDBT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Treatment-naive And Prior ERA Strata: Macitentan 10 Milligrams (mg)', 'description': 'During double-blind treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}, {'id': 'OG001', 'title': 'DB: Treatment-naive And Prior ERA Strata: M/T FDC', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}, {'id': 'OG002', 'title': 'DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.'}, {'id': 'OG003', 'title': 'DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC', 'description': 'During double-blind treatment period, participants who were either treatment-naive or on a predefined stable dose of PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.478', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.394', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.554', 'groupId': 'OG002'}, {'value': '-0.15', 'spread': '0.404', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EDBT (Week 16)', 'description': 'Change from baseline in PAH-SYMPACT in cardiopulmonary symptom domain scores to EDBT were reported. PAH-SYMPACT was a pulmonary arterial hypertension (PAH)-specific patient-reported outcomes questionnaire that consists of 11 symptoms items, 11 impacts items and 1 item on oxygen use. The symptom items were divided into cardiopulmonary and cardiovascular domains, and the impact items were divided into physical and emotional/cognitive domains. Cardiopulmonary symptoms contain 6 items; shortness of breath, fatigue, lack of energy, swelling in ankles or legs, swelling in stomach area, and cough. Scores for the individual items were reported on a 5-point Likert scale, ranging from 0 (no symptom at all) to 4 (very severe symptoms), with higher scores indicated greater symptom severity.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PAH-SYMPACT symptoms analysis set included all participants included in the FAS for whom at least one baseline value of symptoms domain was provided. Treatment-naive participants randomized to both M/T FDC arms (ERA and PDE-5i strata) were counted twice as per planned analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT) in Cardiovascular Symptom Domain Scores to EDBT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Treatment-naive And Prior ERA Strata: Macitentan 10 Milligrams (mg)', 'description': 'During double-blind treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}, {'id': 'OG001', 'title': 'DB: Treatment-naive And Prior ERA Strata: M/T FDC', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}, {'id': 'OG002', 'title': 'DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.'}, {'id': 'OG003', 'title': 'DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC', 'description': 'During double-blind treatment period, participants who were either treatment-naive or on a predefined stable dose of PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.473', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.349', 'groupId': 'OG001'}, {'value': '-0.18', 'spread': '0.612', 'groupId': 'OG002'}, {'value': '-0.10', 'spread': '0.318', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, EDBT (Week 16)', 'description': 'Change from baseline in PAH-SYMPACT in cardiovascular symptom domain scores to EDBT were reported. PAH-SYMPACT is a PAH-specific patient-reported outcomes questionnaire that consists of 11 symptoms items, 11 impacts items and 1 item on oxygen use. The symptom items were divided into cardiopulmonary and cardiovascular domains, and the impact items were divided into physical and emotional/cognitive domains. Cardiovascular symptoms contain 5 items; heart palpitations (heart fluttering), rapid heartbeat, chest pain, chest tightness, and lightheadedness. Scores for the individual items were reported on a 5-point Likert scale, ranging from 0 (no symptom at all) to 4 (very severe symptom), with higher scores indicated greater symptom severity.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PAH-SYMPACT symptoms analysis set included all participants included in the FAS for whom at least one baseline value of symptoms domain was provided. Treatment-naive participants randomized to both M/T FDC arms (ERA and PDE-5i strata) were counted twice as per planned analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Absence of Worsening in World Health Organization (WHO) Functional Class (FC) From Baseline at EDBT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DB: Treatment-naive And Prior ERA Strata: Macitentan 10 Milligrams (mg)', 'description': 'During double-blind treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}, {'id': 'OG001', 'title': 'DB: Treatment-naive And Prior ERA Strata: M/T FDC', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}, {'id': 'OG002', 'title': 'DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.'}, {'id': 'OG003', 'title': 'DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC', 'description': 'During double-blind treatment period, participants who were either treatment-naive or on a predefined stable dose of PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}], 'classes': [{'title': 'Stage: 1 : Class I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '0.590'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '0.561'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '0.522'}, {'value': '12.8', 'groupId': 'OG003', 'lowerLimit': '0.546'}]}]}, {'title': 'Stage: 1 : Class II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}, {'value': '57.9', 'groupId': 'OG001'}, {'value': '63.6', 'groupId': 'OG002'}, {'value': '59.6', 'groupId': 'OG003'}]}]}, {'title': 'Stage: 1 : Class III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}, {'value': '31.8', 'groupId': 'OG002'}, {'value': '25.5', 'groupId': 'OG003'}]}]}, {'title': 'Stage: 1 : Class IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Stage: 1 : Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2.1', 'groupId': 'OG003'}]}]}, {'title': 'Stage: 2 : Class I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}, {'value': '9.1', 'groupId': 'OG002'}, {'value': '7.7', 'groupId': 'OG003'}]}]}, {'title': 'Stage: 2 : Class II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '54.5', 'groupId': 'OG002'}, {'value': '61.5', 'groupId': 'OG003'}]}]}, {'title': 'Stage: 2: Class III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}, {'value': '36.4', 'groupId': 'OG002'}, {'value': '25.6', 'groupId': 'OG003'}]}]}, {'title': 'Stage: 2 : Class IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Stage: 2 : Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16 (EDBT)', 'description': 'Percentage of participants with absence of worsening in FC from baseline to EDBT were reported. The study was adaptive with two stages: Stage 1 and Stage 2. WHO functional classification (FC), PAH range from Class I (no limitation in physical activity, no dyspnea or fatigue, chest pain, or near syncope with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity), Class IV (cannot perform a physical activity without any symptoms, dyspnea and/or fatigue at rest).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least one dose of study treatment (for participants on FDC, at least one dose of either macitentan or tadalafil). Treatment-naive participants randomized to both M/T FDC arms (ERA and PDE-5i strata) are counted twice as per planned analysis. Here, \'N\' overall (number of participants analyzed) signifies the number of participants evaluable, "n" (number analyzed) =number of participants evaluable for specified category.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DB: Treatment-naive and Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)', 'description': 'During double-blind (DB) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}, {'id': 'FG001', 'title': 'DB: Treatment-naive and Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.'}, {'id': 'FG002', 'title': 'DB: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}, {'id': 'FG003', 'title': 'OL: Treatment-naive and Prior ERA Strata: M/T FDC', 'description': 'After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA and received macitentan monotherapy during DB phase entered open label (OL) phase. During the OL phase participants received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching tadalafil 20 mg, orally, once daily for first 7 days (Week 17, titration phase). Subsequently participants received two tablets of tadalafil 20 mg along with one tablet of macitentan 10 mg, orally, once daily for 7 days (Week 18, titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.'}, {'id': 'FG004', 'title': 'OL: Treatment-naive and Prior PDE-5i Strata: M/T FDC', 'description': 'After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of PDE-5i and received tadalafil monotherapy during DB phase entered OL phase. During the OL phase participants received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for the first 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.'}, {'id': 'FG005', 'title': 'OL: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC', 'description': 'After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i and received M/T FDC during DB phase entered OL phase. During the OL phase participants received one tablet macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily.'}], 'periods': [{'title': 'DB Treatment Period (Week 1 to Week 16)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'comment': 'Treatment naive participants are counted once as enrolled but contributed to data twice based on strata (prior ERA/PDE-5i strata). 108 includes one participant who did not receive treatment.', 'groupId': 'FG002', 'numSubjects': '108'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Treated (Safety Analysis Set)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Treatment Naive and Prior ERA Strata: M/T FDC', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '71'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Treatment Naive and Prior PDE-5i Strata: M/T FDC', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '87'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '99'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'OL Treatment Period (Week 17 to Week189)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '43'}, {'groupId': 'FG005', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '38'}, {'groupId': 'FG005', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Initiated prohibited medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Family problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'In open label period, safety was presented using the combination safety set. Combination safety set included all participants randomized to macitentan/tadalafil fixed-dose combination (M/T FDC) in DB period and who received at least 1 dose of M/T FDC in DB treatment and all participants who received at least 1 dose of M/T FDC treatment in OL period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'DB: Treatment-naive and Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg)', 'description': 'During double-blind (DB) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}, {'id': 'BG001', 'title': 'DB: Treatment-naive and Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg)', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily.'}, {'id': 'BG002', 'title': 'DB: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC', 'description': 'During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '148', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '15.85', 'groupId': 'BG000'}, {'value': '53.1', 'spread': '13.66', 'groupId': 'BG001'}, {'value': '48.7', 'spread': '15.78', 'groupId': 'BG002'}, {'value': '50.2', 'spread': '15.36', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'BRAZIL', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'BULGARIA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'CANADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'CHINA', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'GERMANY', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'ITALY', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'JAPAN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'MALAYSIA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'MEXICO', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'POLAND', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'RUSSIAN FEDERATION', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'SOUTH AFRICA', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'TAIWAN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'TURKEY', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety analysis set (SAS) included all randomized participants who received at least one dose of study treatment (for participants on FDC, at least one dose of either macitentan or tadalafil).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-21', 'size': 2481084, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-25T06:26', 'hasProtocol': True}, {'date': '2020-03-20', 'size': 3118898, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-09-25T06:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In total, approximately 170 subjects are planned to be randomized into study to receive either FDC macitentan/tadalafil or macitentan 10 mg or tadalafil 40 mg given once daily and will also receive matching placebos for two other study treatments. Treatment allocation will be stratified based on prior PAH therapy (i.e., treatment-naïve or treated by an Endothelin receptor antagonist or a Phosphodiesterase type-5 inhibitor as a monotherapy) at baseline. Sample size will be re-estimated at interim analysis if study is not terminated early for efficacy/futility up to sample size of 150-250. After completion of double-blind treatment period, subjects will continue study in an open-label treatment (OLT) period for 24 months, which may be prolonged beyond 24 months until macitentan and tadalafil are accessible at required doses, through other options according to local regulations. All assessments at end of double-blind treatment must be completed before subject enters OLT period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2019-04-04', 'resultsFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2019-04-04', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-10-19', 'studyFirstPostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pulmonary Vascular Resistance (PVR) Expressed as the Ratio of Geometric Means of End of Double-blind Treatment (EDBT) to Baseline', 'timeFrame': 'Baseline, EDBT (up to 16 weeks)', 'description': 'Change in PVR expressed as the ratio of geometric means of EDBT to baseline were reported.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to EDBT in 6-minutes Walking Distance (6MWD)', 'timeFrame': 'Baseline, EDBT (Week 16)', 'description': 'Change from baseline to EDBT in 6MWD were reported. 6MWD was measured by 6-minute walk test (6MWT). The test measured the distance an individual was able to walk over a total of six minutes on a hard, flat surface with no obstacles. The goal was for the individual to walk as far as possible in 6 minutes.'}, {'measure': 'Change From Baseline in Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT) in Cardiopulmonary Symptom Domain Scores to EDBT', 'timeFrame': 'Baseline, EDBT (Week 16)', 'description': 'Change from baseline in PAH-SYMPACT in cardiopulmonary symptom domain scores to EDBT were reported. PAH-SYMPACT was a pulmonary arterial hypertension (PAH)-specific patient-reported outcomes questionnaire that consists of 11 symptoms items, 11 impacts items and 1 item on oxygen use. The symptom items were divided into cardiopulmonary and cardiovascular domains, and the impact items were divided into physical and emotional/cognitive domains. Cardiopulmonary symptoms contain 6 items; shortness of breath, fatigue, lack of energy, swelling in ankles or legs, swelling in stomach area, and cough. Scores for the individual items were reported on a 5-point Likert scale, ranging from 0 (no symptom at all) to 4 (very severe symptoms), with higher scores indicated greater symptom severity.'}, {'measure': 'Change From Baseline in Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT) in Cardiovascular Symptom Domain Scores to EDBT', 'timeFrame': 'Baseline, EDBT (Week 16)', 'description': 'Change from baseline in PAH-SYMPACT in cardiovascular symptom domain scores to EDBT were reported. PAH-SYMPACT is a PAH-specific patient-reported outcomes questionnaire that consists of 11 symptoms items, 11 impacts items and 1 item on oxygen use. The symptom items were divided into cardiopulmonary and cardiovascular domains, and the impact items were divided into physical and emotional/cognitive domains. Cardiovascular symptoms contain 5 items; heart palpitations (heart fluttering), rapid heartbeat, chest pain, chest tightness, and lightheadedness. Scores for the individual items were reported on a 5-point Likert scale, ranging from 0 (no symptom at all) to 4 (very severe symptom), with higher scores indicated greater symptom severity.'}, {'measure': 'Percentage of Participants With Absence of Worsening in World Health Organization (WHO) Functional Class (FC) From Baseline at EDBT', 'timeFrame': 'At Week 16 (EDBT)', 'description': 'Percentage of participants with absence of worsening in FC from baseline to EDBT were reported. The study was adaptive with two stages: Stage 1 and Stage 2. WHO functional classification (FC), PAH range from Class I (no limitation in physical activity, no dyspnea or fatigue, chest pain, or near syncope with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity), Class IV (cannot perform a physical activity without any symptoms, dyspnea and/or fatigue at rest).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Arterial Hypertension', 'PAH', 'macitentan', 'tadalafil', 'fixed dose combination therapy'], 'conditions': ['Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)']}, 'referencesModule': {'references': [{'pmid': '41250682', 'type': 'DERIVED', 'citation': 'Fan F, Sun L, Yang Z, Wang L, Wang Q, Li J, Gu H, Xie W, Zhang N, Bin J, Rofael H, Friberg M, Hauser JA. Macitentan Plus Tadalafil Single-Tablet Combination Therapy in Chinese Patients With Pulmonary Arterial Hypertension: A Subgroup Analysis of the A DUE Study. Pulm Circ. 2025 Nov 16;15(4):e70194. doi: 10.1002/pul2.70194. eCollection 2025 Oct.'}, {'pmid': '38267108', 'type': 'DERIVED', 'citation': 'Grunig E, Jansa P, Fan F, Hauser JA, Pannaux M, Morganti A, Rofael H, Chin KM. Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension. J Am Coll Cardiol. 2024 Jan 30;83(4):473-484. doi: 10.1016/j.jacc.2023.10.045.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=AC-077A301&attachmentIdentifier=6a92fb9d-e152-4929-aa6b-06238109e9a5&fileName=AC-077A301_-_RRF_KOM.pptx&versionIdentifier=', 'label': 'RRF KOM slides'}]}, 'descriptionModule': {'briefSummary': "Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet.\n\nThis study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.", 'detailedDescription': 'PAH is characterized by a progressive increase in pulmonary arterial pressure (PAP) and in pulmonary vascular resistance (PVR) potentially leading to right heart failure and death. Current PAH-specific therapeutic options include treatments that target the three pathways (endothelin, nitric oxide, and prostacyclin pathways). While combination treatment is common, FDC pills or tablets that combine two or more PAH-specific therapies are not available, thereby requiring participants to take multiple pills/tablets daily. An FDC is an attractive option for PAH participants because it simplifies the treatment regimen by combining two therapies (which would otherwise involve a total of three tablets: one macitentan 10 mg tablet and two tadalafil 20 mg tablets) into a single tablet. Macitentan is an orally active, non-peptide, potent dual endothelin receptor A and B antagonist. Tadalafil is a selective inhibitor of phosphodiesterase type-5 (PDE-5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP). This study comprises the following consecutive periods: Screening period (lasts up to 30 days), Double-blind treatment period (consists of the titration phase \\[the first 2 weeks\\] and the maintenance phase \\[Week 3 through Week 16\\]), Open-label treatment period, End-of-Treatment (EOT), Safety follow-up (S-FU) period, and End of Study (EOS). The total study duration for a participant will be up to 30 months. Study assessments like physical examinations, vital signs, right heart catheterization, 6-minute walk test will be performed. Safety will be assessed throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed and dated informed consent form (ICF)\n* Confirmed diagnosis of symptomatic PAH in WHO FC II or III\n* Symptomatic PAH belonging to one of the following subgroups of WHO Group 1 pulmonary hypertension:\n\n * Idiopathic\n * Heritable\n * Drug- or toxin-induced\n * Associated with connective tissue disease, HIV infection, portal hypertension or congenital heart disease with simple systemic-to-pulmonary shunt with persistent pulmonary hypertension documented by a right heart catheterization (RHC) ≥ 1 year after surgical repair\n* PAH diagnosis confirmed by hemodynamic evaluation at rest (through central reading), evaluated within 5 weeks prior to randomization:\n\n * Mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, AND\n * Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg, AND\n * Pulmonary vascular resistance (PVR) ≥ 3 WU (i.e., ≥ 240 dyn∙sec∙cm-5)\n* Negative vasoreactivity test in idiopathic, heritable, and drug/toxin-induced PAH. (Participants for whom no vasoreactivity test was performed at diagnosis can be eligible if currently treated with PAH therapy for more than 3 months and PAH diagnosis confirmed by hemodynamic evaluation at least 3 months after introduction of their PAH therapy).\n* Currently receiving a stable dose of ERA or PDE-5i monotherapy for at least 3 months prior to baseline RHC, within the prespecified doses in the study protocol or no history of PAH-specific treatment\n* Participant able to perform the 6MWT with a minimum distance of 100 m and maximum distance of 450 m at Screening\n* A woman of childbearing potential must:\n\n * have negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization\n * agree to undertake monthly urine pregnancy tests during the study and up to at least 30 days after study treatment discontinuation\n * agree to follow the contraception scheme from Screening up to at least 30 days after study treatment discontinuation\n\nExclusion Criteria:\n\n* Treatment with a soluble guanylate cyclase stimulator, L-arginine, any form of prostanoids or prostacyclin-receptor agonists (including oral, inhaled, or infused routes) in the 3-month period prior to start of treatment\n* Treatment with combination therapy of ERA and PDE-5i in the 3-month period prior to start of treatment or history of intolerance to ERA and PDE-5i combination therapy\n* Hypersensitivity to any of the study treatments or any excipient of their formulations\n* Treatment with a strong cytochrome P450 3A4 (CYP3A4) inducer in the 1-month period prior to start of treatment\n* Treatment with a strong CYP3A4 inhibitor or a moderate dual CYP3A4/CYP2C9 inhibitor or co-administration of a combination of moderate CYP3A4 and moderate CYP2C9 inhibitors in the 1-month period prior to start of treatment\n* Treatment with doxazosin\n* Treatment with any form of organic nitrate, either regularly or intermittently\n* Diuretic treatment initiated or dose changed within 1 week prior to the RHC or start of treatment\n* Treatment with another investigational drug in the 3-month period prior to start of treatment\n* Body mass index (BMI) \\> 40 kg/m2 at Screening\n* Known presence of three or more of the following risk factors for heart failure with preserved ejection fraction at Screening:\n\n * BMI \\> 30 kg/m2\n * Diabetes mellitus of any type\n * Essential hypertension (even if well controlled)\n * Coronary artery disease, i.e. history of stable angina or known more than 50% stenosis in a coronary artery or history of myocardial infarction or history of or planned coronary artery bypass grafting and/or coronary artery stenting\n* Known presence of moderate or severe obstructive lung disease any time prior to Screening as specified in study protocol\n* Known presence of moderate or severe restrictive lung disease any time prior to Screening as specified in study protocol\n* Clinically significant aortic or mitral valve disease; pericardial constriction; restrictive or congestive left-sided cardiomyopathy; life-threatening cardiac arrhythmias; significant left ventricular dysfunction; or left ventricular outflow obstruction, in the opinion of the investigator\n* Known permanent atrial fibrillation, in the opinion of the investigator\n* Known or suspected uncontrolled thyroid disease (hypo- or hyperthyroidism)\n* Documented pulmonary veno-occlusive disease\n* Hemoglobin \\< 100 g/L (\\<10 g/dL) at Screening\n* Known severe hepatic impairment as specified in study protocol\n* Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \\> 1.5 × upper limit of normal (ULN) at Screening\n* Severe renal impairment at Screening as specified in study protocol\n* Systemic hypotension at Screening or Randomization and systemic hypertension at Screening as specified in study protocol\n* Acute myocardial infarction or cerebrovascular event (e.g., stroke) within the last 26 weeks prior to Screening\n* Known bleeding disorder, in the opinion of the investigator\n* Loss of vision in one or both eyes because of non-arteritic anterior ischemic optic neuropathy\n* Hereditary degenerative retinal disorders, including retinitis pigmentosa\n* History of priapism, conditions that predispose to priapism (example, sickle cell anemia, multiple myeloma, or leukemia) or anatomical deformation of the penis (example, angulation, cavernosal fibrosis, or Peyronie's disease)\n* Difficulty swallowing large pills/tablets that would interfere with the ability to comply with study treatment regimen\n* Any planned surgical intervention (including organ transplant) during the double-blind treatment period, except minor interventions\n* Exercise training program for cardiopulmonary rehabilitation in the 12-week period prior to start of treatment, or planned to be started during the double-blind period of the study\n* Pregnant, planning to become pregnant or lactating\n* Any known factor or disease that might interfere with treatment adherence, full participation in the study or interpretation of the results as judged by the investigator (e.g., drug or alcohol dependence etc.)\n* Known concomitant life-threatening disease with a life expectancy less than (\\<) 12 months\n* Calcium channel blocker treatment initiated, or dose changed within 3 months prior to right heart catheterization (RHC) at screening"}, 'identificationModule': {'nctId': 'NCT03904693', 'acronym': 'A DUE', 'briefTitle': 'Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Actelion'}, 'officialTitle': 'Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination Therapy', 'orgStudyIdInfo': {'id': 'AC-077A301'}, 'secondaryIdInfos': [{'id': '2014-004786-25', 'type': 'EUDRACT_NUMBER'}, {'id': 'AC-077A301', 'type': 'OTHER', 'domain': 'Actelion Pharmaceuticals Ltd'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FDC therapy + Placebo macitentan + Placebo tadalafil', 'description': 'Subjects to receive FDC macitentan/tadalafil (macitentan 10 mg and tadalafil 40 mg) plus matching placebos for the two other study treatments.', 'interventionNames': ['Drug: FDC macitentan/tadalafil', 'Drug: Placebo macitentan', 'Drug: Placebo tadalafil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Macitentan mono-therapy + Placebo tadalafil + Placebo FDC', 'description': 'Subjects to receive macitentan 10 mg plus matching placebos for the two other study treatments.', 'interventionNames': ['Drug: Macitentan 10 mg', 'Drug: Placebo FDC', 'Drug: Placebo tadalafil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tadalafil mono-therapy + Placebo macitentan + Placebo FDC', 'description': 'Subjects to receive tadalafil 40 mg (2 x 20 mg) plus matching placebos for the two other study treatments.', 'interventionNames': ['Drug: Tadalafil 40 mg', 'Drug: Placebo FDC', 'Drug: Placebo macitentan']}], 'interventions': [{'name': 'FDC macitentan/tadalafil', 'type': 'DRUG', 'otherNames': ['ACT-064992D'], 'description': 'Film-coated tablet with 10 mg macitentan and 40 mg tadalafil, to be administered orally once daily.', 'armGroupLabels': ['FDC therapy + Placebo macitentan + Placebo tadalafil']}, {'name': 'Macitentan 10 mg', 'type': 'DRUG', 'otherNames': ['ACT-064992'], 'description': 'Film-coated tablet with 10 mg macitentan, to be administered orally once daily.', 'armGroupLabels': ['Macitentan mono-therapy + Placebo tadalafil + Placebo FDC']}, {'name': 'Tadalafil 40 mg', 'type': 'DRUG', 'description': 'Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily.', 'armGroupLabels': ['Tadalafil mono-therapy + Placebo macitentan + Placebo FDC']}, {'name': 'Placebo FDC', 'type': 'DRUG', 'description': 'Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.', 'armGroupLabels': ['Macitentan mono-therapy + Placebo tadalafil + Placebo FDC', 'Tadalafil mono-therapy + Placebo macitentan + Placebo FDC']}, {'name': 'Placebo macitentan', 'type': 'DRUG', 'description': 'Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.', 'armGroupLabels': ['FDC therapy + Placebo macitentan + Placebo tadalafil', 'Tadalafil mono-therapy + Placebo macitentan + Placebo FDC']}, {'name': 'Placebo tadalafil', 'type': 'DRUG', 'description': 'Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.', 'armGroupLabels': ['FDC therapy + Placebo macitentan + Placebo tadalafil', 'Macitentan mono-therapy + Placebo tadalafil + Placebo FDC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Providence Medical Foundation', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Healthcare', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'WellStar Health System', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '61614', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'OSF HealthCare Cardiovascular Institute', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40202-1332', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Healthcare', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48912', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Sparrow Clinical Research Institute', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institute Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School Of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89509', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'VA Sierra Nevada Health Care System', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27835', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pitt County Memorial Hospital d/b/a Vidant Medical Center', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Sanford Health', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44503', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': 'St. Elizabeth Hospital Mercy Bon Secors', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Hospital', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Sanford Health', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott White - Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'WVU Health Sciences Center', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin At Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin Froedtert Hospital', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '5000', 'city': 'Adelaide', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '7000', 'city': 'Hobart', 'country': 'Australia', 'facility': 'Pulmonary Arterial Hypertension Clinic', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '4064', 'city': 'Milton', 'country': 'Australia', 'facility': 'Core Research Group', 'geoPoint': {'lat': -27.47039, 'lon': 153.00312}}, {'zip': '30130-100', 'city': 'Belo Horizonte', 'country': 'Brazil', 'facility': 'Universidade Federal De Minas Gerais - Hospital das Clínicas', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '30441-070', 'city': 'Belo Horizonte', 'country': 'Brazil', 'facility': 'Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '18618-686', 'city': 'Botucatu', 'country': 'Brazil', 'facility': 'Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}, {'zip': '60840-285', 'city': 'Fortaleza', 'country': 'Brazil', 'facility': 'Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '74605-020', 'city': 'Goiânia', 'country': 'Brazil', 'facility': 'Universidade Federal de Goias - Hospital das Clinicas da UFG', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '90035-007', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Hospital das Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90035-074', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Irmandade Santa Casa de Misericordia de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90610-000', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '04024-002', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05403-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Das Clinicas Da Faculdade De Medicina Da USP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '1309', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'National Heart Hospital', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1750', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': 'T1Y 6J4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Alberta Health Services', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2G3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': '100029', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '410011', 'city': 'Changsha', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '510120', 'city': 'Guangzhou', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Nanjing', 'country': 'China', 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200433', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '110000', 'city': 'Shenyang', 'country': 'China', 'facility': 'The General Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '300052', 'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '710061', 'city': "Xi'an", 'country': 'China', 'facility': 'The First Affiliated Hospital of Xian Jiaotong University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '128 08', 'city': 'Prague', 'country': 'Czechia', 'facility': 'General University Hospital II.department of Internal Medicine-cardiology and angiology', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '53105', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitatsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitatsklinikum Carl Gustav Carus Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '17475', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'Universitat Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Hamburg Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik am Universitatsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '26871', 'city': 'Papenburg', 'country': 'Germany', 'facility': 'Kardiologische Praxis Papenburg', 'geoPoint': {'lat': 53.07769, 'lon': 7.41516}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '97074', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Klinikum Würzburg Mitte gGmbH Standort Missioklinik', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis Egyetem,Pulmonológiai Klinika', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1096', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '7624', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Pecsi Tudomanyegyetem Klinikai Kozpont', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '6725', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'Szegedi Tudomanyegyetem', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Cardiologia c/o Spedali Civili', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20090', 'city': 'Monza', 'country': 'Italy', 'facility': 'Azienda Ospedaliera San Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '08100', 'city': 'Nuoro', 'country': 'Italy', 'facility': 'Ospedale San Francesco', 'geoPoint': {'lat': 40.31991, 'lon': 9.32568}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'IRCCS Policlinico San Matteo, Università degli studi di Pavi', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Umberto I', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '113-8655', 'city': 'Bunkyō City', 'country': 'Japan', 'facility': 'The University of Tokyo Hospital', 'geoPoint': {'lat': 35.5331, 'lon': 139.4217}}, {'zip': '260 8677', 'city': 'Chiba', 'country': 'Japan', 'facility': 'Chiba University Hospital', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '812 8582', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Kyushu University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '960 1295', 'city': 'Fukushima', 'country': 'Japan', 'facility': 'Fukushima Medical University Hospital', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'zip': '371-0034', 'city': 'Gunma', 'country': 'Japan', 'facility': 'Gunma University Hospital'}, {'zip': '737-8505', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Kure Kyosai Hospital', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '259-1193', 'city': 'Isehara', 'country': 'Japan', 'facility': 'Tokai University Hospital', 'geoPoint': {'lat': 35.39932, 'lon': 139.31019}}, {'zip': '890-8544', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Kagoshima University Hospital', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '920 8641', 'city': 'Kanazawa', 'country': 'Japan', 'facility': 'Kanazawa University Hospital', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '650 0017', 'city': 'Kobe', 'country': 'Japan', 'facility': 'Kobe University Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '860-8556', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Kumamoto University Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '830-0011', 'city': 'Kurume', 'country': 'Japan', 'facility': 'Kurume University Hospital', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'zip': '602-8566', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'University Hospital Kyoto Prefectural University of Medicine', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '606 8507', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto University Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '390 8621', 'city': 'Matsumoto', 'country': 'Japan', 'facility': 'Shinshu University Hospital', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'zip': '181-8611', 'city': 'Mitaka', 'country': 'Japan', 'facility': 'Kyorin University Hospital', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}, {'zip': '852-8501', 'city': 'Nagasaki', 'country': 'Japan', 'facility': 'Nagasaki University Hospital', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '700 8558', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Okayama University Hospital', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '701-1192', 'city': 'Okayama', 'country': 'Japan', 'facility': 'National Hospital Organization Okayama Medical Center', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '060-8543', 'city': 'Sapporo', 'country': 'Japan', 'facility': 'Sapporo Medical University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '060-8648', 'city': 'Sapporo', 'country': 'Japan', 'facility': 'Hokkaido University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '980 8574', 'city': 'Sendai', 'country': 'Japan', 'facility': 'Tohoku University Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '564-8565', 'city': 'Suita-Shi', 'country': 'Japan', 'facility': 'National Cerebral and Cardiovascular Center'}, {'zip': '113-8431', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Juntendo University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '514 8507', 'city': 'Tsu', 'country': 'Japan', 'facility': 'Mie University Hospital', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'zip': '305 8576', 'city': 'Tsukuba', 'country': 'Japan', 'facility': 'University of Tsukuba Hospital', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'zip': '50400', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Institut Jantung Negara (National Heart Institute)', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '94300', 'city': 'Kuching', 'country': 'Malaysia', 'facility': 'Sarawak Heart Center', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}, {'zip': '14080', 'city': 'México', 'country': 'Mexico', 'facility': 'Instituto Nacional de Cardiologia Dr. Ignacio Chavez', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '64718', 'city': 'Monterrey', 'country': 'Mexico', 'facility': 'Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '15 276', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '85-168', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '80 214', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '40 635', 'city': 'Katowice', 'country': 'Poland', 'facility': 'GCM SUM I Oddzial Kardiologii', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '91 347', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-718', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ, Oddzial Kardiologii', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '05-400', 'city': 'Otwock', 'country': 'Poland', 'facility': 'ECZ Otwock Klinika Kardiologii Klinika Krazenia Plucnego Chorob Zakrzepowo Zatorowych i Kardiologii', 'geoPoint': {'lat': 52.10577, 'lon': 21.26129}}, {'zip': '70 111', 'city': 'Szczecin', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny nr 2 PUM Klinika Kardiologii', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '51 124', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Wojewodzki Szpital Specjalistyczny Oddzial Kardiologiczny', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '656055', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'Altay Regional Cardiological Dispensary', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '650002', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Scientific and Research Institution of Cardiovascular Diseases Complex Problems', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '121552', 'city': 'Moscow', 'country': 'Russia', 'facility': 'National Medical Research Center of Cardiology of MoH of Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129090', 'city': 'Moscva', 'country': 'Russia', 'facility': 'GU Moscow Regional Research Clinical Institute n.a. M.F.Vla'}, {'zip': '197341', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443070', 'city': 'Samara', 'country': 'Russia', 'facility': 'Samara Regional Clinical Cardiological Dispensary', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '4001', 'city': 'Durban', 'country': 'South Africa', 'facility': 'Abdullah, IA', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '1820', 'city': 'Lenasia', 'country': 'South Africa', 'facility': 'Dr Kalla', 'geoPoint': {'lat': -26.32052, 'lon': 27.83564}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hosp Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hosp Univ Vall D Hebron', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hosp. Univ. Ramon Y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hosp Univ Fund Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hosp. Univ. La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hosp Clinico Univ de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '39011', 'city': 'Santander', 'country': 'Spain', 'facility': 'Hosp. Univ. Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '45004', 'city': 'Toledo', 'country': 'Spain', 'facility': 'Hosp. Virgen de La Salud', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'zip': '46014', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hosp. Gral. Univ. Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '813', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '10449', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Mackay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang-Gung Memorial Hospital, LinKou Branch', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': '01790', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova University Medical Faculty', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'zip': '6100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University Medical Faculty', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '6500', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University Medical Faculty', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '16310', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}, {'zip': '34096', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University - Cerrahpasa Cardiology Institution', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34096', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University Cerrahpasa Medical Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34899', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University Medical Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University School of Medicine', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '35340', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Dokuz Eylul University Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '34865', 'city': 'Kartal Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi'}, {'zip': '42131', 'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Konya Selcuk University Medical Faculty', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}, {'zip': '33110', 'city': 'Mersin', 'country': 'Turkey (Türkiye)', 'facility': 'Mersin University Medical Faculty', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'overallOfficials': [{'name': 'Hany Rofael, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen, LP'}]}, 'ipdSharingStatementModule': {'url': 'https://www.janssen.com/clinical-trials/transparency', 'ipdSharing': 'YES', 'description': 'The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \\& Johnson is available at www.janssen.com/clinical-trials\\\\transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Actelion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}