Viewing Study NCT01571635


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Study NCT ID: NCT01571635
Status: TERMINATED
Last Update Posted: 2023-06-18
First Post: 2012-04-03
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With Beta( β)- Thalassemia.
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Lebanon']}, 'conditionBrowseModule': {'meshes': [{'id': 'D017086', 'term': 'beta-Thalassemia'}], 'ancestors': [{'id': 'D013789', 'term': 'Thalassemia'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542017', 'term': 'ACE-011'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please Email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Sotatercept development in β-thalassemia indication was stopped and no further patients were enrolled after 1 mg/kg cohort was completed. Due to the early termination of the study and no enrollment of the Expansion Cohort, the primary analyses to determine the recommended dose (RD) and the secondary analysis of QoL change from baseline were not conducted.'}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Dose Level 1a: 0.1 mg/kg', 'description': 'Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Dose Level 1b: 0.3 mg/kg', 'description': 'Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Dose Level 2: 0.5 mg/kg', 'description': 'Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Dose Level 3: 0.75 mg/kg', 'description': 'Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Dose Level 4: 1 mg/kg', 'description': 'Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'BONE MARROW FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'BONE MARROW OEDEMA SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'EXTRAMEDULLARY HAEMOPOIESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'LEUKOCYTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'LYMPH NODE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'LYMPHADENOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'SPLENOMEGALY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'EXTRASYSTOLES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'LEFT ATRIAL DILATATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'LEFT VENTRICULAR DYSFUNCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'PERICARDIAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'SPLINTER HAEMORRHAGES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'VENTRICULAR ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'VENTRICULAR EXTRASYSTOLES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'BENIGN FAMILIAL HAEMATURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'DEAFNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'EAR PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'EXTERNAL EAR INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'TINNITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'AUTOIMMUNE THYROIDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'HYPERPROLACTINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'HYPERTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'THYROID CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'THYROIDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'BLEPHARITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'CONJUNCTIVAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'CONJUNCTIVITIS ALLERGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'DACRYOSTENOSIS ACQUIRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'EYE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'EYE SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'LACRIMAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'LACRIMATION INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'OCULAR HYPERAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 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0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'HOT FLUSH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'PREHYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'THROMBOPHLEBITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'VENOUS RECANALISATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'EXTRAMEDULLARY HAEMOPOIESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'SPLENIC INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'PERICARDIAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'SUBILEUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'LOCAL SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'ANAPHYLACTIC REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'BACTERIAL PROSTATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'CORONA VIRUS INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'PHARYNGOTONSILLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'SUBCUTANEOUS ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'FOREARM FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'LUMBAR VERTEBRAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'PELVIC FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'PUBIS FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'ULNA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'UPPER LIMB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'HEPATIC NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'SPINAL CORD COMPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'THROMBOPHLEBITIS SUPERFICIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Potential Recommended Dose as Determined by Number of Participants Experiencing Dose-Limiting Toxicities and Recommended Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1a: 0.1 mg/kg', 'description': 'Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG001', 'title': 'Dose Level 1b: 0.3 mg/kg', 'description': 'Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG002', 'title': 'Dose Level 2: 0.5 mg/kg', 'description': 'Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG003', 'title': 'Dose Level 3: 0.75 mg/kg', 'description': 'Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG004', 'title': 'Dose Level 4: 1 mg/kg', 'description': 'Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 28 days post the first dose', 'description': 'Number of participants with dose-limiting toxicities (DLT) are used to determine the potential recommended dose (PRD). PRD is defined as the highest dose with up to 1 out of 6 patients experiencing a DLT. DLT is defined as any side effects of the study treatment serious enough to prevent an increase in dose or level of treatment, including at least one of the following: Hypertension ≥ Grade 3 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; Hgb \\> 14 g/dL sustained for four weeks; any NCI CTCAE toxicity ≥ Grade 3. Grade 3 is defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily life.\n\nPRD was identified as 1 mg/kg. Due to study termination, no patients were enrolled after 1 mg/kg cohort or in the Expansion Cohort. Thus, primary analyses to determine recommended dose (RD) were not conducted.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Red Blood Cell Transfusion Burden Reduction From Baseline During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1a: 0.1 mg/kg', 'description': 'Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG001', 'title': 'Dose Level 1b: 0.3 mg/kg', 'description': 'Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG002', 'title': 'Dose Level 2: 0.5 mg/kg', 'description': 'Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG003', 'title': 'Dose Level 3: 0.75 mg/kg', 'description': 'Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG004', 'title': 'Dose Level 4: 1 mg/kg', 'description': 'Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}], 'classes': [{'title': '≥ 25% reduction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': '≥ 33% reduction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '≥ 50% reduction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to the last dose of study treatment (up to approximately 112 months)', 'description': 'Transfusion burden at baseline is defined as the total number of units of RBC transfusions that participants received within 168 days (24 weeks) prior to the first dose of study therapy. Transfusion burden during treatment is defined as the total number of RBC transfusion units that each participant received during the treatment divided by the treatment duration and multiplied by 168 days. The result is a 168-day transfusion burden average. Baseline measurement includes RBC transfusion history for transfusion dependent and non-transfusion dependent participants, starting at 168 days prior to enrollment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population Transfusion Dependent-All participants who received at least one dose of sotatercept and are transfusion dependent.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hemoglobin Level Increase From Baseline in Non-Transfusion Dependent B-Thalassemia Intermedia Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1a: 0.1 mg/kg', 'description': 'Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG001', 'title': 'Dose Level 1b: 0.3 mg/kg', 'description': 'Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG002', 'title': 'Dose Level 2: 0.5 mg/kg', 'description': 'Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG003', 'title': 'Dose Level 3: 0.75 mg/kg', 'description': 'Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG004', 'title': 'Dose Level 4: 1 mg/kg', 'description': 'Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}], 'classes': [{'title': '9-week episode with Hgb ≥ 1.0 g/dl change from baseline (non-transfusion dependent participants)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': '9-week episode with Hgb ≥ 1.5 g/dl change from baseline (non-transfusion dependent participants)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '12-Week episode with Hgb ≥ 1.0 g/dl change from baseline (non-transfusion dependent participants)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '12-Week episode with Hgb ≥ 1.5 g/dl change from baseline (non-transfusion dependent participants)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measurements were taken in 9 and 12-week intervals, from baseline up to approximately 112 months', 'description': 'The Number of participants with a change in Hemoglobin levels will be listed for non-RBC transfusion dependent participants. Baseline assessments are the average of the last two measurements prior to the start of therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Non-RBC transfusion dependent participants-participants who are in the safety population and are not transfusion dependent. This is a subgroup of the B-thalassemia intermedia population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1a: 0.1 mg/kg', 'description': 'Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG001', 'title': 'Dose Level 1b: 0.3 mg/kg', 'description': 'Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG002', 'title': 'Dose Level 2: 0.5 mg/kg', 'description': 'Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG003', 'title': 'Dose Level 3: 0.75 mg/kg', 'description': 'Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG004', 'title': 'Dose Level 4: 1 mg/kg', 'description': 'Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}], 'classes': [{'title': 'Participants with at least one TEAE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'TEAE leading to dose interruption', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Participants with at least one serious TEAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Participants with at least one grade 2/3/4 TEAE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Participants with at least one drug-related grade 2/3/4 TEAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Participants with at least one serious drug- related TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Participants with at least one TEAE leading to sotatercept withdrawal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 112 days after the last dose of study treatment (up to 115 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. Treatment emergent adverse events (TEAE) are defined as an AE that began after the start of trial medication treatment; or if the event was continuous from baseline and was serious, trial medication-related, or resulted in death, discontinuation, or interruption or reduction of trial therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Concentrations of Sotatercept in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1a: 0.1 mg/kg', 'description': 'Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG001', 'title': 'Dose Level 1b: 0.3 mg/kg', 'description': 'Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG002', 'title': 'Dose Level 2: 0.5 mg/kg', 'description': 'Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG003', 'title': 'Dose Level 3: 0.75 mg/kg', 'description': 'Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG004', 'title': 'Dose Level 4: 1 mg/kg', 'description': 'Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}], 'classes': [{'title': 'Dose 1, Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '598.3', 'groupId': 'OG000', 'lowerLimit': '289.2', 'upperLimit': '1345.4'}, {'value': '1454.05', 'groupId': 'OG001', 'lowerLimit': '1006.6', 'upperLimit': '2768.3'}, {'value': '3045.45', 'groupId': 'OG002', 'lowerLimit': '1586.7', 'upperLimit': '4480'}, {'value': '5837.65', 'groupId': 'OG003', 'lowerLimit': '3238.1', 'upperLimit': '10590.5'}, {'value': '3874', 'groupId': 'OG004', 'lowerLimit': '2264.9', 'upperLimit': '7003'}]}]}, {'title': 'Dose 1, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '388.7', 'groupId': 'OG000', 'lowerLimit': '98.4', 'upperLimit': '1046'}, {'value': '1150.1', 'groupId': 'OG001', 'lowerLimit': '550.3', 'upperLimit': '2158.4'}, {'value': '2329.75', 'groupId': 'OG002', 'lowerLimit': '952', 'upperLimit': '3005.5'}, {'value': '4279.65', 'groupId': 'OG003', 'lowerLimit': '2107.8', 'upperLimit': '6692'}, {'value': '2405.6', 'groupId': 'OG004', 'lowerLimit': '1825.3', 'upperLimit': '4605.5'}]}]}, {'title': 'Dose 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '294.75', 'groupId': 'OG000', 'lowerLimit': '112.9', 'upperLimit': '547.1'}, {'value': '770.3', 'groupId': 'OG001', 'lowerLimit': '317.2', 'upperLimit': '1300.1'}, {'value': '1468.05', 'groupId': 'OG002', 'lowerLimit': '682', 'upperLimit': '2550.5'}, {'value': '2955.2', 'groupId': 'OG003', 'lowerLimit': '1257.5', 'upperLimit': '4450.8'}, {'value': '1701.5', 'groupId': 'OG004', 'lowerLimit': '888.6', 'upperLimit': '4267.9'}]}]}, {'title': 'Dose 2, Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '683.1', 'groupId': 'OG000', 'lowerLimit': '250.1', 'upperLimit': '1210.6'}, {'value': '2065', 'groupId': 'OG001', 'lowerLimit': '1363.7', 'upperLimit': '3626.4'}, {'value': '4136.8', 'groupId': 'OG002', 'lowerLimit': '1661.9', 'upperLimit': '5573.8'}, {'value': '7753.35', 'groupId': 'OG003', 'lowerLimit': '5046.4', 'upperLimit': '8805.6'}, {'value': '5148.1', 'groupId': 'OG004', 'lowerLimit': '3537.4', 'upperLimit': '10418.7'}]}]}, {'title': 'Dose 3, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '325.35', 'groupId': 'OG000', 'lowerLimit': '228.8', 'upperLimit': '790'}, {'value': '956.8', 'groupId': 'OG001', 'lowerLimit': '380.6', 'upperLimit': '1552.6'}, {'value': '2157.3', 'groupId': 'OG002', 'lowerLimit': '422', 'upperLimit': '3088.4'}, {'value': '3628.45', 'groupId': 'OG003', 'lowerLimit': '653.5', 'upperLimit': '6429.1'}, {'value': '2602.6', 'groupId': 'OG004', 'lowerLimit': '822.2', 'upperLimit': '5668.1'}]}]}, {'title': 'Dose 3, Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '758.1', 'groupId': 'OG000', 'lowerLimit': '444', 'upperLimit': '1232'}, {'value': '2319.9', 'groupId': 'OG001', 'lowerLimit': '1475.6', 'upperLimit': '3667.4'}, {'value': '4507.3', 'groupId': 'OG002', 'lowerLimit': '2077.8', 'upperLimit': '5762.3'}, {'value': '8373.05', 'groupId': 'OG003', 'lowerLimit': '5345.5', 'upperLimit': '12177.8'}, {'value': '6050.8', 'groupId': 'OG004', 'lowerLimit': '3892.5', 'upperLimit': '12139.6'}]}]}, {'title': 'Dose 4, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '334.85', 'groupId': 'OG000', 'lowerLimit': '298', 'upperLimit': '1014.9'}, {'value': '1022.3', 'groupId': 'OG001', 'lowerLimit': '348.8', 'upperLimit': '2096.9'}, {'value': '2441.6', 'groupId': 'OG002', 'lowerLimit': '784', 'upperLimit': '2845.3'}, {'value': '4137.1', 'groupId': 'OG003', 'lowerLimit': '1447.1', 'upperLimit': '6126.6'}, {'value': '2869.2', 'groupId': 'OG004', 'lowerLimit': '1478.9', 'upperLimit': '4787.7'}]}]}, {'title': 'Dose 5, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '385.1', 'groupId': 'OG000', 'lowerLimit': '287.5', 'upperLimit': '467.5'}, {'value': '1473.9', 'groupId': 'OG001', 'lowerLimit': '762.1', 'upperLimit': '2764.4'}, {'value': '1618.8', 'groupId': 'OG002', 'lowerLimit': '953.4', 'upperLimit': '3440'}, {'value': '4449.7', 'groupId': 'OG003', 'lowerLimit': '2340.4', 'upperLimit': '5887.8'}, {'value': '3048', 'groupId': 'OG004', 'lowerLimit': '1125.5', 'upperLimit': '6529.3'}]}]}, {'title': 'Dose 6, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '297.60', 'groupId': 'OG000', 'lowerLimit': '227.80', 'upperLimit': '484.40'}, {'value': '1368.10', 'groupId': 'OG001', 'lowerLimit': '449.70', 'upperLimit': '2363.20'}, {'value': '2266.40', 'groupId': 'OG002', 'lowerLimit': '1115.20', 'upperLimit': '3788.50'}, {'value': '4062.80', 'groupId': 'OG003', 'lowerLimit': '1481.10', 'upperLimit': '6584.00'}, {'value': '2780.80', 'groupId': 'OG004', 'lowerLimit': '1479.20', 'upperLimit': '7896.70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Dose 1, Day 8; Dose 1, Day 15; Dose 2, Day 1; Dose 2, Day 8; Dose 3, Day 1; Dose 3, Day 8; Dose 4, Day 1; Dose 5, Day 1; Dose 6, Day 1', 'description': 'Sotatercept was administered as a subcutaneous injection every 21 days during the Treatment Period. Pharmacokinetic (PK) samples were collected at the pre-specified timepoints.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibody (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1a: 0.1 mg/kg', 'description': 'Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG001', 'title': 'Dose Level 1b: 0.3 mg/kg', 'description': 'Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG002', 'title': 'Dose Level 2: 0.5 mg/kg', 'description': 'Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG003', 'title': 'Dose Level 3: 0.75 mg/kg', 'description': 'Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG004', 'title': 'Dose Level 4: 1 mg/kg', 'description': 'Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 4 months after last dose (up to approximately 116 months)', 'description': "The number of participants with Anti-Sotatercept Antibody is a summary of antidrug antibody (ADA) status for ADA-evaluated participants. A participant is counted as 'positive' if there is any positive result captured during the study, a participant is counted as 'negative' if there is no positive result captured during the study. ADA data was collected Day 1 in dose schedules 1 through 6. Starting from Dose 7, ADA was measured at Day 1 every 3 Doses, then finally at the post-treatment follow-up visit at Month 2 and Month 4.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Quality of Life (QOL) Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1a: 0.1 mg/kg', 'description': 'Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG001', 'title': 'Dose Level 1b: 0.3 mg/kg', 'description': 'Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG002', 'title': 'Dose Level 2: 0.5 mg/kg', 'description': 'Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG003', 'title': 'Dose Level 3: 0.75 mg/kg', 'description': 'Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'OG004', 'title': 'Dose Level 4: 1 mg/kg', 'description': 'Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}], 'timeFrame': 'From pre-dose up to Dose 8 (168 days/6months) and Dose 16 (336 days/12months) only', 'description': 'The number of participants in the expansion cohort experiencing changes from baseline in Quality of Life. QOL was planned to be assessed at Day 168 (6 months) and Day 336 (12 months), after Dose 1 Day 1, independent of Dose Delay for participants enrolled in the Expansion Cohort only. QOL was planned to be calculated using the SF-36 and the FACT Anemia. The SF-36 is a Medical Outcomes Study (MOS) consisting of 36 questions developed to determine health status. The SF-36 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The FACT Anemia measures fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) Measurement System.\n\nDue to early study termination, no participants were enrolled in the expansion cohort and QOL was not assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Expansion cohort'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Level 1a: 0.1 mg/kg', 'description': 'Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'FG001', 'title': 'Dose Level 1b: 0.3 mg/kg', 'description': 'Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'FG002', 'title': 'Dose Level 2: 0.5 mg/kg', 'description': 'Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'FG003', 'title': 'Dose Level 3: 0.75 mg/kg', 'description': 'Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'FG004', 'title': 'Dose Level 4: 1 mg/kg', 'description': 'Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'The Sponsor decided to stop advancing sotatercept development in the β-thalassemia indication; therefore, the study participants enrollment stopped during the Treatment Period. No participants were enrolled in the dose level 1.5 mg/kg that was planned in the protocol.\n\nAdditionally, the protocol planned to enroll approximately 30 participants in an expansion cohort once the potential recommended dose (PRD) was defined. Due to early termination of the study, the expansion cohort was not opened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose Level 1a: 0.1 mg/kg', 'description': 'Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'BG001', 'title': 'Dose Level 1b: 0.3 mg/kg', 'description': 'Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'BG002', 'title': 'Dose Level 2: 0.5 mg/kg', 'description': 'Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'BG003', 'title': 'Dose Level 3: 0.75 mg/kg', 'description': 'Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'BG004', 'title': 'Dose Level 4: 1 mg/kg', 'description': 'Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '8.21', 'groupId': 'BG000'}, {'value': '40.0', 'spread': '9.89', 'groupId': 'BG001'}, {'value': '38.5', 'spread': '7.63', 'groupId': 'BG002'}, {'value': '44.0', 'spread': '10.29', 'groupId': 'BG003'}, {'value': '41.0', 'spread': '10.36', 'groupId': 'BG004'}, {'value': '39.5', 'spread': '9.22', 'groupId': 'BG005'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}]}]}], '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': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'whyStopped': 'Business objectives have changed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'dispFirstSubmitDate': '2015-12-11', 'completionDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2012-04-03', 'dispFirstSubmitQcDate': '2016-04-01', 'resultsFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2012-04-04', 'dispFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-23', 'studyFirstPostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Potential Recommended Dose as Determined by Number of Participants Experiencing Dose-Limiting Toxicities and Recommended Dose', 'timeFrame': 'From first dose up to 28 days post the first dose', 'description': 'Number of participants with dose-limiting toxicities (DLT) are used to determine the potential recommended dose (PRD). PRD is defined as the highest dose with up to 1 out of 6 patients experiencing a DLT. DLT is defined as any side effects of the study treatment serious enough to prevent an increase in dose or level of treatment, including at least one of the following: Hypertension ≥ Grade 3 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; Hgb \\> 14 g/dL sustained for four weeks; any NCI CTCAE toxicity ≥ Grade 3. Grade 3 is defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily life.\n\nPRD was identified as 1 mg/kg. Due to study termination, no patients were enrolled after 1 mg/kg cohort or in the Expansion Cohort. Thus, primary analyses to determine recommended dose (RD) were not conducted.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Red Blood Cell Transfusion Burden Reduction From Baseline During Treatment', 'timeFrame': 'From baseline to the last dose of study treatment (up to approximately 112 months)', 'description': 'Transfusion burden at baseline is defined as the total number of units of RBC transfusions that participants received within 168 days (24 weeks) prior to the first dose of study therapy. Transfusion burden during treatment is defined as the total number of RBC transfusion units that each participant received during the treatment divided by the treatment duration and multiplied by 168 days. The result is a 168-day transfusion burden average. Baseline measurement includes RBC transfusion history for transfusion dependent and non-transfusion dependent participants, starting at 168 days prior to enrollment.'}, {'measure': 'Number of Participants With Hemoglobin Level Increase From Baseline in Non-Transfusion Dependent B-Thalassemia Intermedia Participants', 'timeFrame': 'Measurements were taken in 9 and 12-week intervals, from baseline up to approximately 112 months', 'description': 'The Number of participants with a change in Hemoglobin levels will be listed for non-RBC transfusion dependent participants. Baseline assessments are the average of the last two measurements prior to the start of therapy.'}, {'measure': 'Number of Participants Experiencing Adverse Events (AEs)', 'timeFrame': 'From first dose up to 112 days after the last dose of study treatment (up to 115 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. Treatment emergent adverse events (TEAE) are defined as an AE that began after the start of trial medication treatment; or if the event was continuous from baseline and was serious, trial medication-related, or resulted in death, discontinuation, or interruption or reduction of trial therapy.'}, {'measure': 'Concentrations of Sotatercept in Serum', 'timeFrame': 'Dose 1, Day 8; Dose 1, Day 15; Dose 2, Day 1; Dose 2, Day 8; Dose 3, Day 1; Dose 3, Day 8; Dose 4, Day 1; Dose 5, Day 1; Dose 6, Day 1', 'description': 'Sotatercept was administered as a subcutaneous injection every 21 days during the Treatment Period. Pharmacokinetic (PK) samples were collected at the pre-specified timepoints.'}, {'measure': 'Number of Participants With Anti-Drug Antibody (ADA)', 'timeFrame': 'From first dose up to 4 months after last dose (up to approximately 116 months)', 'description': "The number of participants with Anti-Sotatercept Antibody is a summary of antidrug antibody (ADA) status for ADA-evaluated participants. A participant is counted as 'positive' if there is any positive result captured during the study, a participant is counted as 'negative' if there is no positive result captured during the study. ADA data was collected Day 1 in dose schedules 1 through 6. Starting from Dose 7, ADA was measured at Day 1 every 3 Doses, then finally at the post-treatment follow-up visit at Month 2 and Month 4."}, {'measure': 'Number of Participants Experiencing Quality of Life (QOL) Change From Baseline', 'timeFrame': 'From pre-dose up to Dose 8 (168 days/6months) and Dose 16 (336 days/12months) only', 'description': 'The number of participants in the expansion cohort experiencing changes from baseline in Quality of Life. QOL was planned to be assessed at Day 168 (6 months) and Day 336 (12 months), after Dose 1 Day 1, independent of Dose Delay for participants enrolled in the Expansion Cohort only. QOL was planned to be calculated using the SF-36 and the FACT Anemia. The SF-36 is a Medical Outcomes Study (MOS) consisting of 36 questions developed to determine health status. The SF-36 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The FACT Anemia measures fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) Measurement System.\n\nDue to early study termination, no participants were enrolled in the expansion cohort and QOL was not assessed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Beta-Thalassaemia'], 'conditions': ['Beta Thalassemia Major', 'Beta Thalassemia Intermedia']}, 'referencesModule': {'references': [{'pmid': '30337358', 'type': 'BACKGROUND', 'citation': 'Cappellini MD, Porter J, Origa R, Forni GL, Voskaridou E, Galacteros F, Taher AT, Arlet JB, Ribeil JA, Garbowski M, Graziadei G, Brouzes C, Semeraro M, Laadem A, Miteva D, Zou J, Sung V, Zinger T, Attie KM, Hermine O. Sotatercept, a novel transforming growth factor beta ligand trap, improves anemia in beta-thalassemia: a phase II, open-label, dose-finding study. Haematologica. 2019 Mar;104(3):477-484. doi: 10.3324/haematol.2018.198887. Epub 2018 Oct 18.'}, {'type': 'BACKGROUND', 'citation': 'Cappellini M, et al. A Phase 2a, Open-Label, Dose-Finding Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With Beta ( )-Thalassemia: Interim Results. Presented at the 55th Annual Meeting of the American Society of Hematology (ASH), December 7-10, 2013, New Orleans, LA. Abstract No. 3448'}, {'type': 'BACKGROUND', 'citation': '"Porter J, et al. Interim Results From a Phase 2A, Open-Label, Dose-Finding Study To Determine The Safety, Efficacy, And Tolerability of Sotatercept (ACE-001) In Adults with Beta-Thalassemia. Presented at the 19thCongress of the European Hematology Association, June 12-15, 2015, Milan, Italy. Abstract No. S622 "'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/us/en/home.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'Dose finding study to determine the safety and tolerability of Sotatercept (ACE-011) in adults with Beta (β)-Thalassemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 18 years of age at the time of signing the informed consent document with a diagnosis of β-thalassemia major (including all subtypes) or β-thalassemia intermedia.\n* For transfusion dependent subjects: permanent transfusion dependency is defined as requiring packed red blood cells (pRBCs) and iron chelation therapy:\n\n * Average transfusion requirement of at least 2 units/30 days of pRBCs (Gale, 2011) confirmed for a minimum of 168 days (six months) immediately preceding enrollment (study Day 1, first Dose);\n * No transfusion-free period of more than 45 consecutive days during the 168 days immediately preceding enrollment (study Day 1, first Dose);\n * Prior transfusion hemoglobin levels ≤ 10.5 g/dL.\n* For non-transfusion dependent subjects: non-transfusion dependency is defined as a transfusion free for a minimum of 168 days immediately preceding enrollment (study Day 1, first Dose), with the exception of ≤ to one episode of transfusion in the period of a minimum of 168 days immediately preceding enrollment (study Day 1, first Dose) (One episode of transfusion is defined as ≤ 4 transfusion units administered, occurred within 42 days \\[first transfusion is counted as day 1\\] due to concurrent illness \\[e.g. infection\\], \\[Guidelines Clin Management of Thalassaemia, 2008\\]). (This inclusion criteria is not valid for France).\n* Performance status: Eastern Cooperative Oncology Group (ECOG) score of 0 to 1\n* No concurrent severe hepatic disease:\n\n * Aspartate Aminotransferase (AST) or Alanine Transaminase (ALT) no greater than 3 x upper limit of normal (ULN);\n * Albumin ≥ 3 g/dL.\n* Serum creatinine ≤ 1.5 x ULN.\n* Females of childbearing potential participating in the study are to use highly effective methods of birth control during study participation and for 112 days (approximately five times the mean terminal half-life of sotatercept \\[23 days\\] based on multiple-dose PK data) following the last dose of sotatercept. FCBP must have a negative serum beta Human Chorionic Gonadotropin (β-HCG) pregnancy test within three days of Sotatercept dosing (Day 1). Subjects must be counseled concerning measures to be used to prevent pregnancy and potential toxicities prior to the first dose of sotatercept. A FCBP is a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy or who has not been postmenopausal for at least 24 consecutive months (i.e., who has had menses at some time in the preceding 24 months).\n* Males must agree to use a latex condom during any sexual contact with FCBSs while participating in the study and for 112 days following the last dose of Sotatercept, even if he has undergone a successful vasectomy. Subjects must be counseled concerning measures to be used to prevent pregnancy and potential toxicities prior to the first dose of sotatercept.\n* Agreement to adhere to the study visit schedule, understand and comply with all protocol requirements.\n* Understand and provide written informed consent.\n\nExclusion Criteria:\n\n* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing participating in the study.\n* Evidence of active Hepatitis C antibody (HCV), Hepatitis B surface antigen (HBsAg and HB core Ab), or Human Immunodeficiency Virus (HIV) antibody.\n* Known history of thromboembolic events ≥ Grade 3 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 (current active minor version).\n* Subjects with insulin dependent diabetes.\n* Subjects with major cardiac problems such as:\n\n * Major risk of heart failure, confirmed with myocardiac T2\\* ≤ 10 ms. Myocardiac T2\\* performed in the last one and a half years prior to subject enrollment (study Day 1, first Dose) will be considered valid.\n * Cardiac arrhythmia which requires treatment (i.e. atrial fibrillation).\n* Treatment with another investigational drug or device \\< 28 days prior to study entry.\n* Use of an Erythropoiesis Stimulating Agent (ESA) within the 28 days prior to enrollment (study Day 1, first Dose).\n* Subjects on hydroxyurea treatment for which the dose was changed in the last one year prior to subject enrollment (study Day 1, first Dose).\n* Subjects on anticoagulant therapy, such as warfarin.\n* Subjects who started bisphosphonates within the last three months prior to subject enrollment (study Day 1, first Dose).\n* Pregnant or lactating females.\n* Uncontrolled hypertension. Controlled hypertension for this protocol is considered ≤ Grade 1 according to NCI CTCAE version 4.0 (current active minor version) (Appendix B).\n* A history of major organ damage including:\n\n * Liver disease with ALT \\> 3x ULN or histopathological evidence of liver cirrhosis on liver biopsy;\n * Heart disease with ejection fraction ≥ Grade 2 according to NCI CTCAE version 4.0 (current active minor version);\n * Kidney disease with a calculated creatinine clearance \\< 40 mL/min (Cockcroft-Gault formula);\n * Pulmonary fibrosis or pulmonary hypertension as confirmed by a specialist.\n* Adrenal insufficiency.\n* Heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher (Appendix C).\n* Major surgery within 30 days prior to study Day 1 (subjects must have completely recovered from any previous surgery prior to study Day 1).\n* History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the Investigational Product (see Investigator Brochure).'}, 'identificationModule': {'nctId': 'NCT01571635', 'briefTitle': 'Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With Beta( β)- Thalassemia.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 2A, Open-label Dose Finding Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With BETA(b)-THALASSEMIA.', 'orgStudyIdInfo': {'id': 'ACE-011-B-THAL-001'}, 'secondaryIdInfos': [{'id': '2011-005659-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sotatercept dose level 0.1mg/kg', 'description': 'Experimental 0.1 mg/kg -Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period', 'interventionNames': ['Drug: SOTATERCEPT (ACE-011)']}, {'type': 'EXPERIMENTAL', 'label': 'Sotatercept dose level 0.3mg/ kg', 'description': 'Experimental 0.3 mg/kg - Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period', 'interventionNames': ['Drug: SOTATERCEPT (ACE-011)']}, {'type': 'EXPERIMENTAL', 'label': 'Sotatercept dose level 0.5mg/kg', 'description': 'Experimental 0.5 mg/kg -Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period', 'interventionNames': ['Drug: SOTATERCEPT (ACE-011)']}, {'type': 'EXPERIMENTAL', 'label': 'Sotatercept dose level 0.75mg/kg', 'description': 'Experimental 0.75 mg/kg - Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period', 'interventionNames': ['Drug: SOTATERCEPT (ACE-011)']}, {'type': 'EXPERIMENTAL', 'label': 'Sotatercept dose level 1.0mg/kg', 'description': 'Experimental 1.0 mg/kg -Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period', 'interventionNames': ['Drug: SOTATERCEPT (ACE-011)']}, {'type': 'EXPERIMENTAL', 'label': 'Sotatercept dose level 1.5mg/kg', 'description': 'Experimental 1.5 mg/kg -Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period', 'interventionNames': ['Drug: SOTATERCEPT (ACE-011)']}], 'interventions': [{'name': 'SOTATERCEPT (ACE-011)', 'type': 'DRUG', 'otherNames': ['(ACE-011)'], 'description': '0.1 mg/kg to 1.5mg/kg Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period.', 'armGroupLabels': ['Sotatercept dose level 0.1mg/kg', 'Sotatercept dose level 0.3mg/ kg', 'Sotatercept dose level 0.5mg/kg', 'Sotatercept dose level 0.75mg/kg', 'Sotatercept dose level 1.0mg/kg', 'Sotatercept dose level 1.5mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Créteil', 'country': 'France', 'facility': 'Groupe Hospitalier Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hospital of Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Local Institution - 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