Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05223920
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2021-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013920', 'term': 'Thrombocythemia, Essential'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D013922', 'term': 'Thrombocytosis'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730033', 'term': 'bomedemstat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@MSD.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors (ICMJE) authorship requirements.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Death and adverse events up to ~32 months', 'description': 'All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Essential Thrombocythemia (ET)', 'description': "Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.", 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 45, 'seriousNumAtRisk': 52, 'deathsNumAffected': 2, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Myelofibrosis (MF)', 'description': "Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.", 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 28, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 16, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 27, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 14, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 13, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary occult blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 24, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 21, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 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0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Glioblastoma multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Heavy menstrual bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experience an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Essential Thrombocythemia (ET)', 'description': "Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN."}, {'id': 'OG001', 'title': 'Myelofibrosis (MF)', 'description': "Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN."}], 'classes': [{'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~32 months', 'description': 'An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who experienced an AE is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study intervention'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinue Study Intervention Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Essential Thrombocythemia (ET)', 'description': "Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN."}, {'id': 'OG001', 'title': 'Myelofibrosis (MF)', 'description': "Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN."}], 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~32 months', 'description': 'An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who discontinued study intervention due to an AE is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study intervention'}, {'type': 'PRIMARY', 'title': 'Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Essential Thrombocythemia (ET)', 'description': "Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN."}, {'id': 'OG001', 'title': 'Myelofibrosis (MF)', 'description': "Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN."}], 'classes': [{'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-101.570', 'spread': '92.6876', 'groupId': 'OG001'}]}]}, {'title': 'Day 339', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-67.645', 'spread': '249.0079', 'groupId': 'OG001'}]}]}, {'title': 'Day 509', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.920', 'spread': '143.1692', 'groupId': 'OG001'}]}]}, {'title': 'Day 679', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-61.000', 'spread': '396.2520', 'groupId': 'OG001'}]}]}, {'title': 'Day 849', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-38.840', 'spread': 'NA', 'comment': 'Standard deviation is not estimable due to only 1 participant in the group.', 'groupId': 'OG001'}]}]}, {'title': 'Day 924', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.575', 'spread': '10.3308', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Days 169, 339, 509, 679, 849 and 924', 'description': 'Mean Spleen volume reduction (mL) in participants with MF as measured by central laboratory imaging analysis of MRI (or CT where applicable) approximately every 48 weeks. Per protocol only participants with MF were analyzed for this outcome measure. The change in spleen volume from baseline is presented.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent to treat (mITT) population included all participants who were enrolled in the study, received at least 1 dose of study intervention, and who had a nonmissing baseline and at least 1 nonmissing postbaseline efficacy assessment. Participants were analyzed according to treatment received in the study. Per protocol only participants with MF were analyzed for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Essential Thrombocythemia (ET)', 'description': "Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN."}, {'id': 'OG001', 'title': 'Myelofibrosis (MF)', 'description': "Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN."}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000', 'lowerLimit': '62.7', 'upperLimit': '88.0'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000', 'lowerLimit': '58.2', 'upperLimit': '84.7'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000', 'lowerLimit': '57.5', 'upperLimit': '83.8'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000', 'lowerLimit': '64.7', 'upperLimit': '88.7'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.8', 'groupId': 'OG000', 'lowerLimit': '80.4', 'upperLimit': '97.7'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.4', 'groupId': 'OG000', 'lowerLimit': '76.9', 'upperLimit': '96.5'}]}]}, {'title': 'Day 198', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000', 'lowerLimit': '73.2', 'upperLimit': '94.9'}]}]}, {'title': 'Day 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000', 'lowerLimit': '67.3', 'upperLimit': '91.8'}]}]}, {'title': 'Day 254', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.5', 'groupId': 'OG000', 'lowerLimit': '64.7', 'upperLimit': '90.2'}]}]}, {'title': 'Day 282', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '59.7', 'upperLimit': '86.8'}]}]}, {'title': 'Day 310', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000', 'lowerLimit': '66.6', 'upperLimit': '91.6'}]}]}, {'title': 'Day 338', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.7', 'groupId': 'OG000', 'lowerLimit': '69.3', 'upperLimit': '93.2'}]}]}, {'title': 'Day 367', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000', 'lowerLimit': '60.5', 'upperLimit': '87.9'}]}]}, {'title': 'Day 395', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.0', 'groupId': 'OG000', 'lowerLimit': '62.4', 'upperLimit': '89.4'}]}]}, {'title': 'Day 423', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '64.4', 'upperLimit': '90.9'}]}]}, {'title': 'Day 451', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000', 'lowerLimit': '66.5', 'upperLimit': '92.5'}]}]}, {'title': 'Day 479', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.7', 'groupId': 'OG000', 'lowerLimit': '58.8', 'upperLimit': '88.2'}]}]}, {'title': 'Day 507', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '80.4', 'upperLimit': '99.9'}]}]}, {'title': 'Day 536', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000', 'lowerLimit': '74.0', 'upperLimit': '99.9'}]}]}, {'title': 'Day 564', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000', 'lowerLimit': '59.5', 'upperLimit': '98.3'}]}]}, {'title': 'Day 592', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000', 'lowerLimit': '39.0', 'upperLimit': '94.0'}]}]}, {'title': 'Day 620', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '42.1', 'upperLimit': '99.6'}]}]}, {'title': 'Day 648', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '35.9', 'upperLimit': '99.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Days 29, 57, 85, 113, 141, 169, 198, 226, 254, 282, 310, 338, 367, 395, 423, 451, 479, 507, 536, 564, 592, 620, and 648', 'description': 'Blood samples were taken at designated time points to determine platelet count. Percentage of participants with ET who achieve a reduction of platelet counts to \\<= 400 K/uL (400 x 10\\^9/L) in the absence of new thromboembolic events is presented.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent to treat (mITT) population included all participants who were enrolled in the study, received at least 1 dose of study intervention, and who had a nonmissing baseline and at least 1 nonmissing postbaseline efficacy assessment. Per protocol only participants with ET were analyzed for this outcome measure. Participants were analyzed according to treatment received in the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Essential Thrombocythemia (ET)', 'description': "Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN."}, {'id': 'FG001', 'title': 'Myelofibrosis (MF)', 'description': "Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Transferred to Extension Study MK-3543-017 (NCT06351631)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Subject decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': "Participants with Myeloproliferative Neoplasms (MPNs) who participated in a prior bomedemstat study such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003 (NCT04254978) (referred to hereafter as 'feeder studies') were included in the recruitment.", 'preAssignmentDetails': 'Participants were assigned to either the Essential thrombocythemia (ET) arm or Myelofibrosis (MF) arm based on prior diagnosis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Essential Thrombocythemia (ET)', 'description': "Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN."}, {'id': 'BG001', 'title': 'Myelofibrosis (MF)', 'description': "Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65.8', 'spread': '11.01', 'groupId': 'BG000'}, {'value': '65.3', 'spread': '9.68', 'groupId': 'BG001'}, {'value': '65.6', 'spread': '10.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Spleen Volume by Magnetic resonance imaging/computerized tomography (MRI/CT) in mL', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '835.21', 'groupId': 'BG001', 'lowerLimit': '98.88', 'upperLimit': '3085.92'}, {'value': '835.21', 'groupId': 'BG002', 'lowerLimit': '98.88', 'upperLimit': '3085.92'}]}]}], 'paramType': 'MEDIAN', 'description': 'Baseline spleen volume was measured for myelofibrosis participants via MRI/CT scan in milliliters (mL).', 'unitOfMeasure': 'mL', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Analysis population contained all MF participants who had baseline measurement.'}, {'title': 'Baseline Platelet Counts in thousands per microliter (10^3 cells/μL)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '380.4', 'spread': '207.44', 'groupId': 'BG000'}, {'value': '190.5', 'spread': '209.64', 'groupId': 'BG001'}, {'value': '312.4', 'spread': '226.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline platelet count measured in 10\\^3 cells/μL was obtained for both ET and MF participants.', 'unitOfMeasure': '10^3 cells/μL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-13', 'size': 2259809, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-14T15:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2021-08-31', 'resultsFirstSubmitDate': '2025-08-14', 'studyFirstSubmitQcDate': '2022-01-24', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-17', 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to ~32 months', 'description': 'An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who experienced an AE is presented.'}, {'measure': 'Percentage of Participants Who Discontinue Study Intervention Due to an AE', 'timeFrame': 'Up to ~32 months', 'description': 'An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who discontinued study intervention due to an AE is presented.'}, {'measure': 'Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF.', 'timeFrame': 'Baseline and Days 169, 339, 509, 679, 849 and 924', 'description': 'Mean Spleen volume reduction (mL) in participants with MF as measured by central laboratory imaging analysis of MRI (or CT where applicable) approximately every 48 weeks. Per protocol only participants with MF were analyzed for this outcome measure. The change in spleen volume from baseline is presented.'}, {'measure': 'Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events', 'timeFrame': 'Baseline and Days 29, 57, 85, 113, 141, 169, 198, 226, 254, 282, 310, 338, 367, 395, 423, 451, 479, 507, 536, 564, 592, 620, and 648', 'description': 'Blood samples were taken at designated time points to determine platelet count. Percentage of participants with ET who achieve a reduction of platelet counts to \\<= 400 K/uL (400 x 10\\^9/L) in the absence of new thromboembolic events is presented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thrombocythemia, Essential', 'Primary Myelofibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat administered orally once daily in participants with a Myeloproliferative Neoplasm (MPN) who participated in a prior bomedemstat study such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003 (NCT04254978) (referred to hereafter as 'feeder studies')."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion Criteria include, but are not limited to:\n\n* Has completed at least one Treatment Period (TP) in a prior bomedemstat Myeloproliferative Neoplasms (MPN) protocol (such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003) (NCT04254978).\n* In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat.\n\nExclusion Criteria:\n\nExclusion Criteria include, but are not limited to:\n\n* Ongoing participation in another investigational study (except observational studies).\n* A history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted).\n* Current use of a prohibited medication (e.g., romiplostim).\n* Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's safety, ability to give informed consent, or comply with the trial protocol.\n* Is pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.\n* Women of childbearing potential (WOCBP) and fertile men unwilling to agree to use an approved method of contraception from time of enrollment until 14 days after last bomedemstat dose."}, 'identificationModule': {'nctId': 'NCT05223920', 'briefTitle': 'An Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)'}, 'officialTitle': 'A Multi-Center, Open Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Patients With Myeloproliferative Neoplasms (MPNs) Enrolled in a Prior Bomedemstat Clinical Study', 'orgStudyIdInfo': {'id': 'IMG-7289-CTP-202'}, 'secondaryIdInfos': [{'id': 'MK-3543-005', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'IMG-7289', 'type': 'OTHER', 'domain': 'ImagoBio'}, {'id': '2021-002452-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bomedemstat', 'description': 'All participants will receive bomedemstat via oral capsule daily for 169 days with additional treatment continuing in patients deriving clinical benefit.', 'interventionNames': ['Drug: Bomedemstat']}], 'interventions': [{'name': 'Bomedemstat', 'type': 'DRUG', 'otherNames': ['IMG-7289', 'MK-3543'], 'description': 'Capsule (oral)', 'armGroupLabels': ['Bomedemstat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Leonard M. Miller', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UMPC Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2065', 'city': 'Saint Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital'}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Gold Coast Hospital and Health Service', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universittsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '2100', 'city': 'Varese', 'state': 'VA', 'country': 'Italy', 'facility': 'Ospedale di Circolo-a Fondazione Macchi', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': '15121', 'city': 'Alessandria', 'country': 'Italy', 'facility': 'Azienda Ospedaliera SS. Antonio', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Careggi - S.O.D. Ematologia (CRIMM)', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria di Bologna', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '2025', 'city': 'Papatoetoe', 'state': 'Aukland', 'country': 'New Zealand', 'facility': 'Middlemore Clinical Trials', 'geoPoint': {'lat': -36.9682, 'lon': 174.84019}}, {'zip': '0622', 'city': 'Takapuna', 'state': 'Aukland', 'country': 'New Zealand', 'facility': 'Waitemata District Health Board', 'geoPoint': {'lat': -36.79167, 'lon': 174.77583}}, {'zip': 'NW1 12G', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and Saint Thomas' NHS Foundation Trus", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}