Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 2:49 PM
Study NCT ID:
NCT00931606
Status:
TERMINATED
Last Update Posted:
2023-09-13
First Post:
2009-05-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542017', 'term': 'ACE-011'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'All information concerning Sotatercept is considered confidential and shall remain the sole property of the Sponsor. No publication or disclosure of study results will be permitted except as specified in a separate, written, agreement between the Sponsor and the Investigator.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This is an acquired study. No restrictions were imposed on time on current chemotherapy prior to study entry, therefore PFS could have gone beyond the study duration. The time from start of current chemotherapy could have occurred prior to study start and collected as prior anticancer therapy, therefore the upper limit of the confidence interval in the "Sotatercept 0.5 mg/kg" arm, "1791.0 days", didn\'t exceed the timeframe of 281 days after study start.'}}, 'adverseEventsModule': {'timeFrame': 'Up to Day 281', 'description': 'The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Total', 'description': 'Total for all participants', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 25, 'seriousNumAtRisk': 30, 'deathsNumAffected': 7, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 19, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nodal arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oral discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Peritoneal effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 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'100.0'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '5.6', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '71.6'}]}]}, {'title': 'Received less frequent chemotherapy and showed a response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '70.8'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '81.6'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '60.2'}, {'value': '22.2', 'groupId': 'OG004', 'lowerLimit': '9.1', 'upperLimit': '61.4'}]}]}], 'analyses': [{'pValue': '>0.999', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Overall', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Overall', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.524', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Overall', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG003', 'OG004'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Overall', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.333', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Weekly Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.333', 'groupIds': ['OG001', 'OG003'], 'groupDescription': 'Weekly Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.333', 'groupIds': ['OG003', 'OG004'], 'groupDescription': 'Weekly Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.236', 'groupIds': ['OG001', 'OG003'], 'groupDescription': 'Less Frequent Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.429', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Less Frequent Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.519', 'groupIds': ['OG003', 'OG004'], 'groupDescription': 'Less Frequent Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Hematopoietic response rate is defined as the percentage of participants who had increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of study treatment in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA). The percentage of participants who achieved hematopoietic response is presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to ~175 Days', 'description': 'An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced AEs is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Intervention Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to ~85 Days', 'description': 'An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study intervention due to AEs is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG004', 'title': 'All Sotatercept-treated Participants', 'description': 'Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '52.2'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '48.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '60.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '52.2'}, {'value': '5.6', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '27.3'}]}]}, {'title': 'Received weekly chemotherapy and showed a response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '84.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '84.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '97.5'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '97.5'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '52.2'}]}]}, {'title': 'Received less frequent chemotherapy and showed a response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '70.8'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '57.9'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '70.8'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '60.2'}, {'value': '5.6', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '36.0'}]}]}], 'analyses': [{'pValue': '>0.999', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Overall', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG003', 'OG004'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Overall', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Less Frequent Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG003', 'OG004'], 'groupDescription': 'Less Frequent Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days is presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study treatment for at least 2 months (57 days).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG004', 'title': 'All Sotatercept-treated Participants', 'description': 'Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '71.6'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '60.0'}, {'value': '75.0', 'groupId': 'OG002', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '71.6'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '13.3', 'upperLimit': '59.0'}]}]}, {'title': 'Received weekly chemotherapy and showed a response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '84.2'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '11.1', 'groupId': 'OG004', 'lowerLimit': '5.3', 'upperLimit': '85.3'}]}]}, {'title': 'Received less frequent chemotherapy and showed a response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '57.9'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '9.4', 'upperLimit': '99.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '60.2'}, {'value': '22.2', 'groupId': 'OG004', 'lowerLimit': '9.1', 'upperLimit': '61.4'}]}]}], 'analyses': [{'pValue': '>0.999', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-values greater than 0.999, are reported as "\\>0.999".', 'groupDescription': 'Overall', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Overall', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.206', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Overall', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG003', 'OG004'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Overall', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.333', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Weekly Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'P-values greater than 0.999, are reported as "\\>0.999".', 'groupDescription': 'Weekly Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG003', 'OG004'], 'pValueComment': 'P-values greater than 0.999, are reported as "\\>0.999".', 'groupDescription': 'Weekly Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.429', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Less Frequent Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Less Frequent Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.143', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Less Frequent Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.519', 'groupIds': ['OG003', 'OG004'], 'groupDescription': 'Less Frequent Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Percentage of participants achieving hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 11 g/dL for 28 consecutive days is presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG004', 'title': 'All Sotatercept-treated Participants', 'description': 'Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '71.6'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '60.0'}, {'value': '75.0', 'groupId': 'OG002', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '71.6'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '13.3', 'upperLimit': '59.0'}]}]}, {'title': 'Received weekly chemotherapy and showed a response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '84.2'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '11.1', 'groupId': 'OG004', 'lowerLimit': '5.3', 'upperLimit': '85.3'}]}]}, {'title': 'Received less frequent chemotherapy and showed a response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '57.9'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '9.4', 'upperLimit': '99.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '60.2'}, {'value': '22.2', 'groupId': 'OG004', 'lowerLimit': '9.1', 'upperLimit': '61.4'}]}]}], 'analyses': [{'pValue': '>0.999', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Overall', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Overall', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.206', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Overall', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG003', 'OG004'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Overall', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.333', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Weekly Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Weekly Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG003', 'OG004'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Weekly Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.429', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Less Frequent Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '>0.999', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'P-values greater than 0.999 are reported as "\\>0.999".', 'groupDescription': 'Less Frequent Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.143', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Less Frequent Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}, {'pValue': '0.519', 'groupIds': ['OG003', 'OG004'], 'groupDescription': 'Less Frequent Chemotherapy', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper and Pearson exact approach'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days is presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).'}, {'type': 'SECONDARY', 'title': 'Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.0', 'spread': '20.30', 'groupId': 'OG001'}, {'value': '46.5', 'spread': '14.85', 'groupId': 'OG002'}, {'value': '29.0', 'spread': 'NA', 'comment': 'NA = Standard deviation cannot be calculated for 1 participant.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 1 g/dL from baseline to the last time there is hemoglobin ≥ 1 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for ≥ 1 g/dL from baseline is presented.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥1 g/dL and less than 2 g/dL increase from baseline.'}, {'type': 'SECONDARY', 'title': 'Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'spread': 'NA', 'comment': 'NA = Standard deviation cannot be calculated for 1 participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 2 g/dL from baseline to the last time there is hemoglobin ≥ 2 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥2 g/dL and less than 11 g/dL increase from baseline.'}, {'type': 'SECONDARY', 'title': 'Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'spread': 'NA', 'comment': 'NA = Standard deviation cannot be calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '50.0', 'spread': '9.90', 'groupId': 'OG002'}, {'value': '29.0', 'spread': 'NA', 'comment': 'NA = Standard deviation cannot be calculated for 1 participant.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 11 g/dL from baseline to the last time there is hemoglobin ≥ 11 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days), and had a hematopoietic response of ≥11 g/dL increase from baseline.'}, {'type': 'SECONDARY', 'title': 'Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.0', 'spread': '20.30', 'groupId': 'OG001'}, {'value': '50.0', 'spread': '9.90', 'groupId': 'OG002'}, {'value': '29.0', 'spread': 'NA', 'comment': 'NA = Standard deviation cannot be calculated for 1 participant.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 1 g/dL and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 1 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days), and had a hematopoietic response of ≥ 1 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.'}, {'type': 'SECONDARY', 'title': 'Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'spread': 'NA', 'comment': 'NA = Standard deviation cannot be calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '50.0', 'spread': '9.90', 'groupId': 'OG002'}, {'value': '29.0', 'spread': 'NA', 'comment': 'NA = Standard deviation cannot be calculated for 1 participant.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 2 g/dL, and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 2 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 2 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.'}, {'type': 'SECONDARY', 'title': 'Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG001', 'lowerLimit': '72.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG003', 'lowerLimit': '112', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Time to achieve hematopoietic response based on ≥ 1 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 1 g/dL that was maintained for at least 28 consecutive days. The data for time to achieve hematopoietic response for hemoglobin ≥ 1 g/dL from baseline is presented.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 1 g/dL increase from baseline.'}, {'type': 'SECONDARY', 'title': 'Time to Achieve Hematopoietic Response of Hemoglobin ≥ 2 g/dL Increase From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Time to achieve hematopoietic response based on ≥ 2 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 2 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 2 g/dL increase from baseline.'}, {'type': 'SECONDARY', 'title': 'Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG000', 'lowerLimit': '28.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG001', 'lowerLimit': '100.0', 'upperLimit': 'NA'}, {'value': '56.0', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG003', 'lowerLimit': '112.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Time to achieve hematopoietic response based on hemoglobin ≥ 11 g/dL, defined as the time from first dose of study treatment to the first hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had hematopoietic response of ≥ 11 g/dL increase from baseline.'}, {'type': 'SECONDARY', 'title': 'Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG000', 'lowerLimit': '28.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG001', 'lowerLimit': '21.0', 'upperLimit': 'NA'}, {'value': '56.0', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG003', 'lowerLimit': '112.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Time to achieve hematopoietic response based on multiple criteria categories, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 1 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 1 g/dL and/or ≥ 11 g/dL from baseline is presented.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 1 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.'}, {'type': 'SECONDARY', 'title': 'Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG000', 'lowerLimit': '28.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '56.0', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to small number of responses.', 'groupId': 'OG003', 'lowerLimit': '112.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Time to achieve hematopoietic response, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 2 g/dL and/or ≥ 11 g/dL from baseline is presented.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 2 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'title': 'Overall RBC Transfusions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Overall ESAs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Overall Received RBC Transfusions or ESAs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '44.4', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 1 to Prior to Day 29 RBC Transfusions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 1 to Prior to Day 29 ESAs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 1 to Prior to Day 29 Received RBC Transfusions or ESAs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 29 to Prior to Day 57 RBC Transfusions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 29 to Prior to Day 57 ESAs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 29 to Prior to Day 57 Received RBC Transfusions or ESAs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 57 to Prior to Day 85 RBC Transfusions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 57 to Prior to Day 85 ESAs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 57 to Prior to Day 85 Received RBC Transfusions or ESAs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 85 to Prior to Day 141 RBC Transfusions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 85 to Prior to Day 141 ESAs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 85 to Prior to Day 141 Received RBC Transfusions or ESAs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 141', 'description': 'The percentage of participants who received RBC transfusion or treatment with an ESA in each study treatment group as well as within each cycle of each study treatment is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Not Evaluable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Not Applicable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 64', 'description': 'ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 64 is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.'}, {'type': 'SECONDARY', 'title': 'Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}]}]}, {'title': 'Non-complete Response/Non-progressive disease', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}]}]}, {'title': 'Not Evaluable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Not Applicable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 64', 'description': 'ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 64 is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.'}, {'type': 'SECONDARY', 'title': 'Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Not Evaluable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Not Applicable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '66.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 113', 'description': 'ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 113 is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.'}, {'type': 'SECONDARY', 'title': 'Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}]}]}, {'title': 'Non-complete Response/Non-progressive disease', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}]}]}, {'title': 'Not Evaluable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Not Applicable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 113', 'description': 'ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 113 is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}, {'id': 'OG004', 'title': 'All Sotatercept-treated Participants', 'description': 'Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '188.0', 'groupId': 'OG000', 'lowerLimit': '64.0', 'upperLimit': '188.0'}, {'value': '196.0', 'groupId': 'OG001', 'lowerLimit': '97.0', 'upperLimit': '219.0'}, {'value': '187.0', 'groupId': 'OG002', 'lowerLimit': '134.0', 'upperLimit': '1791.0'}, {'value': '157.0', 'comment': 'NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.', 'groupId': 'OG003', 'lowerLimit': '84.0', 'upperLimit': 'NA'}, {'value': '169.0', 'groupId': 'OG004', 'lowerLimit': '108.0', 'upperLimit': '219.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of chemotherapy (which could have occurred prior to study start) up to Study Day 281', 'description': 'PFS was defined as the time from start of the chemotherapy regimen (which could have occurred prior to study start and collected as prior anticancer therapy) to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 is presented.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'FG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'FG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was terminated early after 30 participants were enrolled due to slower than expected rate of enrollment as a result of changes in guidance for the treatment of participants with breast cancer and chemotherapy induced anemia (CIA).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Sotatercept 0.1 mg/kg', 'description': 'Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'BG001', 'title': 'Sotatercept 0.3 mg/kg', 'description': 'Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'BG002', 'title': 'Sotatercept 0.5 mg/kg', 'description': 'Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously every 28 days up to 4 doses.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '9.38', 'groupId': 'BG000'}, {'value': '50.8', 'spread': '8.51', 'groupId': 'BG001'}, {'value': '55.6', 'spread': '12.53', 'groupId': 'BG002'}, {'value': '49.2', 'spread': '10.62', 'groupId': 'BG003'}, {'value': '51.9', 'spread': '9.83', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], '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': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'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'}]}, {'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'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '67.38', 'spread': '18.338', 'groupId': 'BG000'}, {'value': '71.80', 'spread': '9.500', 'groupId': 'BG001'}, {'value': '69.94', 'spread': '9.953', 'groupId': 'BG002'}, {'value': '79.62', 'spread': '9.926', 'groupId': 'BG003'}, {'value': '71.49', 'spread': '12.647', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Participants weight in kilograms is presented as the mean for each treatment arm.', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Chemotherapy Frequency', 'classes': [{'title': 'Weekly', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'Less Frequently', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Chemotherapy frequency among the Modified Intent to Treat Group was differentiated as either weekly or less frequently for participants.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2009-03-13', 'size': 10339038, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-22T09:06', 'hasProtocol': True}, {'date': '2009-10-27', 'size': 2413195, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-22T09:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'administrative reasons (slow patient enrollment)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'dispFirstSubmitDate': '2017-11-14', 'completionDateStruct': {'date': '2010-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2009-05-22', 'dispFirstSubmitQcDate': '2017-11-14', 'resultsFirstSubmitDate': '2023-05-22', 'studyFirstSubmitQcDate': '2009-07-01', 'dispFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-21', 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved a Hematopoietic Response', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Hematopoietic response rate is defined as the percentage of participants who had increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of study treatment in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA). The percentage of participants who achieved hematopoietic response is presented.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to ~175 Days', 'description': 'An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced AEs is reported.'}, {'measure': 'Number of Participants Who Discontinued Study Intervention Due to an Adverse Event', 'timeFrame': 'Up to ~85 Days', 'description': 'An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study intervention due to AEs is reported.'}, {'measure': 'Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days is presented.'}, {'measure': 'Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Percentage of participants achieving hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 11 g/dL for 28 consecutive days is presented.'}, {'measure': 'Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days is presented.'}, {'measure': 'Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 1 g/dL from baseline to the last time there is hemoglobin ≥ 1 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for ≥ 1 g/dL from baseline is presented.'}, {'measure': 'Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 2 g/dL from baseline to the last time there is hemoglobin ≥ 2 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented.'}, {'measure': 'Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 11 g/dL from baseline to the last time there is hemoglobin ≥ 11 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented.'}, {'measure': 'Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 1 g/dL and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 1 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented.'}, {'measure': 'Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 2 g/dL, and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 2 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented.'}, {'measure': 'Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Time to achieve hematopoietic response based on ≥ 1 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 1 g/dL that was maintained for at least 28 consecutive days. The data for time to achieve hematopoietic response for hemoglobin ≥ 1 g/dL from baseline is presented.'}, {'measure': 'Time to Achieve Hematopoietic Response of Hemoglobin ≥ 2 g/dL Increase From Baseline', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Time to achieve hematopoietic response based on ≥ 2 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 2 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented.'}, {'measure': 'Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Time to achieve hematopoietic response based on hemoglobin ≥ 11 g/dL, defined as the time from first dose of study treatment to the first hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented.'}, {'measure': 'Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Time to achieve hematopoietic response based on multiple criteria categories, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 1 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 1 g/dL and/or ≥ 11 g/dL from baseline is presented.'}, {'measure': 'Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL', 'timeFrame': 'Baseline and Up to ~145 Days', 'description': 'Time to achieve hematopoietic response, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 2 g/dL and/or ≥ 11 g/dL from baseline is presented.'}, {'measure': 'Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA', 'timeFrame': 'Up to Day 141', 'description': 'The percentage of participants who received RBC transfusion or treatment with an ESA in each study treatment group as well as within each cycle of each study treatment is presented.'}, {'measure': 'Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1).', 'timeFrame': 'Baseline and Day 64', 'description': 'ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 64 is presented.'}, {'measure': 'Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1.', 'timeFrame': 'Day 64', 'description': 'ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 64 is presented.'}, {'measure': 'Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1.', 'timeFrame': 'Day 113', 'description': 'ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 113 is presented.'}, {'measure': 'Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1.', 'timeFrame': 'Day 113', 'description': 'ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 113 is presented.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From start of chemotherapy (which could have occurred prior to study start) up to Study Day 281', 'description': 'PFS was defined as the time from start of the chemotherapy regimen (which could have occurred prior to study start and collected as prior anticancer therapy) to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 is presented.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anemia', 'metastatic', 'breast', 'cancer'], 'conditions': ['Chemotherapy Induced Anemia']}, 'referencesModule': {'references': [{'pmid': '26370220', 'type': 'BACKGROUND', 'citation': 'Raftopoulos H, Laadem A, Hesketh PJ, Goldschmidt J, Gabrail N, Osborne C, Ali M, Sherman ML, Wang D, Glaspy JA, Puccio-Pick M, Zou J, Crawford J. Sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia in patients with metastatic breast cancer or advanced or metastatic solid tumors treated with platinum-based chemotherapeutic regimens: results from two phase 2 studies. Support Care Cancer. 2016 Apr;24(4):1517-25. doi: 10.1007/s00520-015-2929-9. Epub 2015 Sep 14.'}], 'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the percentage of participants in each sotatercept dose regimen who achieve a hematopoietic response during the treatment period including up to 2 months after the last dose of sotatercept treatment of chemotherapy-induced anemia (CIA) in participants with metastatic breast cancer. Hematopoietic response was defined as an increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of sotatercept in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a histologically confirmed diagnosis of breast cancer documented by cytology or biopsy.\n* Has evidence of metastatic breast cancer with a minimum of one lesion per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v 1.1) criteria.\n* Is receiving a chemotherapy regimen including one of the following: anthracycline, taxane, gemcitabine, vinorelbine or capecitabine.\n* Has planned treatment with the same chemotherapy regimen for a minimum of 9 weeks after Day 1 of study intervention administration.\n* ≥ 30 days elapsed (from Day 1) since previous treatment with an erythropoiesis stimulating agent (ESA) (including treatment with intravenous (IV) iron) for chemotherapy induced anemia.\n* ≥ 7 days elapsed (from Day 1) since the last red blood cell (RBC) transfusion and receipt of ≤ 2 units of blood in the past 30 days.\n* Life expectancy of ≥ 6 months.\n\nExclusion Criteria:\n\n* Has had prior radiation therapy to \\> 20% of the whole skeleton.\n* Has had \\> 5 prior chemotherapy treatment regimens for metastatic breast cancer.\n* Has a history of autoimmune or hereditary hemolysis or gastrointestinal bleeding.\n* Has clinically significant pulmonary, endocrine, neurologic, gastrointestinal, hepatic or genitourinary disease unrelated to underlying hematologic disorder.\n* Has heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher.\n* Has a recent history of thrombosis, deep vein thrombosis (DVT), pulmonary emboli, or embolic stroke, occurring within the last 6 months.\n* Has untreated central nervous system (CNS) metastases or CNS metastases treated with whole brain radiotherapy \\< 6 months prior to Day 1.\n* Has a diagnosis of a myeloid malignancy or known history of myelodysplasia.\n* Has a history of second malignancy within 5 years (except excised and cured basal cell carcinoma, squamous cell carcinoma of the skin or cervical carcinoma in situ).\n* Has had administration of IV antibiotics or febrile (temperature elevation \\> 38 ° C) within 14 days of Day 1.\n* Has uncontrolled hypertension.\n* Has known history of hepatitis B surface antigen (HBsAg and HB core antibody (Ab)), human immunodeficiency virus (HIV) antibody or active hepatitis C.\n* Has clinically significant iron (transferrin saturation \\< 20%), vitamin B12, or folate deficiency.\n* Has a history of anemia as a result of inherited hemoglobinopathy such as sickle cell anemia or thalassemia.\n* Has a history of autoimmune or hereditary hemolysis; active gastrointestinal bleeding (within the last 6 months as compared to Day 1).\n* Has received treatment with another investigational drug or device within 1 month prior to Day 1.\n* Is pregnant or lactating.\n* Has a history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product.\n* Has had major surgery within 30 days prior to Day 1 (patients must have completely recovered from any previous surgery prior to Day 1).'}, 'identificationModule': {'nctId': 'NCT00931606', 'briefTitle': 'Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 2, Double-blind, Randomized, Placebo-Controlled Study of ACE-011 for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '7962-012'}, 'secondaryIdInfos': [{'id': 'A011-08', 'type': 'OTHER', 'domain': 'Acceleron pharma'}, {'id': 'MK-7962-012', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sotatercept 0.1 mg/kg', 'description': 'Participants will receive sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.', 'interventionNames': ['Biological: Sotatercept']}, {'type': 'EXPERIMENTAL', 'label': 'Sotatercept 0.3 mg/kg', 'description': 'Participants will receive sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.', 'interventionNames': ['Biological: Sotatercept']}, {'type': 'EXPERIMENTAL', 'label': 'Sotatercept 0.5 mg/kg', 'description': 'Participants will receive sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.', 'interventionNames': ['Biological: Sotatercept']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo subcutaneously every 28 days up to 4 doses.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sotatercept', 'type': 'BIOLOGICAL', 'otherNames': ['ACE-011'], 'description': 'up to 4 subcutaneous doses of sotatercept given once every 28 days', 'armGroupLabels': ['Sotatercept 0.1 mg/kg', 'Sotatercept 0.3 mg/kg', 'Sotatercept 0.5 mg/kg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'up to 4 subcutaneous doses of placebo given once every 28 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sedona', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 34.86974, 'lon': -111.76099}}, {'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'city': 'Corona', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.87529, 'lon': -117.56644}}, {'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'city': 'Montebello', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 34.00946, 'lon': -118.10535}}, {'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'city': 'Hinsdale', 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