Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-04 @ 12:02 PM
Study NCT ID:
NCT04173494
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2019-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C546012', 'term': 'N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide'}, {'id': 'D003613', 'term': 'Danazol'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'Sierra Oncology LLC - a GSK company'}, 'certainAgreement': {'otherDetails': 'GlaxoSmithKline (GSK) agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 24 for Randomized Double-Blind Treatment Period and From Week 24 to a maximum of 151 weeks for the Open-Label Extended Treatment Period', 'description': 'Serious adverse events (SAEs) and non-SAEs were measured in the Safety analysis set, which included all participants in the ITT analysis set who received at least one dose of study drug. All-cause mortality was measured in the ITT analysis set, which included all randomized participants. Data are presented per treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period', 'description': 'Participants were randomized to receive 200 mg of MMB orally QD and a DAN-placebo orally BID during the randomized 24-week double-blind treatment period.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 108, 'seriousNumAtRisk': 130, 'deathsNumAffected': 25, 'seriousNumAffected': 45}, {'id': 'EG001', 'title': 'DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 55, 'seriousNumAtRisk': 65, 'deathsNumAffected': 16, 'seriousNumAffected': 26}, {'id': 'EG002', 'title': 'MMB 200 mg QD- Open-Label Extended Treatment Period', 'description': 'Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period.', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 57, 'seriousNumAtRisk': 93, 'deathsNumAffected': 23, 'seriousNumAffected': 30}, {'id': 'EG003', 'title': 'DAN 300 mg BID to MMB 200 mg QD- Open-Label Extended Treatment Period', 'description': 'Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 28, 'seriousNumAtRisk': 41, 'deathsNumAffected': 8, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 34, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 50, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 22, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 40, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 18, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 18, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 24, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 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'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Enterobacter sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Escherichia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Infective exacerbation of chronic obstructive airways disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pneumonia influenzal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Splenic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Periprosthetic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Sarcopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Personality change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pulmonary arterial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Restrictive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Symptom Score (TSS) Response Rate at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.62', 'groupId': 'OG000', 'lowerLimit': '17.49', 'upperLimit': '32.94'}, {'value': '9.23', 'groupId': 'OG001', 'lowerLimit': '3.46', 'upperLimit': '19.02'}]}]}], 'analyses': [{'pValue': '0.0095', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Cochran-Mantel-Haenszel', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.67', 'ciLowerLimit': '5.54', 'ciUpperLimit': '25.81', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': 'Myelofibrosis Symptom Assessment Form (MFSAF) TSS version (v) 4.0 response rate was defined as percentage of participants with a \\>= 50 percent (%) reduction from Baseline in mean MFSAF TSS over consecutive 28-day period immediately before end of Week 24. TSS response rate was measured using MFSAF v4.0. MFSAF v4.0 comprises 7 domains representing 7 most relevant symptoms of myelofibrosis (MF) identified through existing participant and clinician-based evidence: fatigue,night sweats,pruritus,abdominal discomfort,pain under left ribs,early satietyand bone pain. Participants scored each symptom domain using an 11-point numeric rating scale ranging from 0(absent) to 10(worst imaginable). The MFSAF TSS was calculated as sum of scores of 7 domains for a possible range of scores of 0 to 70, with a higher TSS corresponding to more severe symptoms. A reduction from Baseline corresponded to a lessening of MF symptoms. Baseline was the last assessment done before or on the day of first dose date.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Measured in the Intent-To-Treat (ITT) Analysis Set, which included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Transfusion Independence (TI) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '22.28', 'upperLimit': '38.66'}, {'value': '20.00', 'groupId': 'OG001', 'lowerLimit': '11.10', 'upperLimit': '31.77'}]}]}], 'analyses': [{'pValue': '0.0116', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Non-inferiority difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.58', 'ciLowerLimit': '1.86', 'ciUpperLimit': '25.30', 'estimateComment': 'Non-inferiority difference, defined as p(MMB) - (0.8) \\*p(DAN) where p(MMB) is percentage of participants with TI status in MMB arm and p(DAN) is percentage of participants with TI status in DAN arm.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'If the lower bound of the confidence interval (CI) is greater than 0, MMB was to be declared non-inferior to DAN.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'TI status was defined as not receiving red blood cell (RBC) or whole blood transfusion for \\>=12 weeks, with no hemoglobin (Hgb) level \\< 8 grams per deciliter (g/dL) during the same interval. Percentage of participants with TI have been presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}, {'type': 'SECONDARY', 'title': 'Splenic Response Rate (SRR) of >=25% at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.23', 'groupId': 'OG000', 'lowerLimit': '30.79', 'upperLimit': '48.18'}, {'value': '6.15', 'groupId': 'OG001', 'lowerLimit': '1.70', 'upperLimit': '15.01'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Cochran-Mantel-Haenszel', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.05', 'ciLowerLimit': '22.59', 'ciUpperLimit': '43.51', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': 'Splenic response rate (SRR) is defined as the percentage of participants who have reduction in spleen volume of \\>=25% from Baseline at the end of Week 24. Baseline was the last assessment done before or on the day of first dose date.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MFSAF TSS at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.36', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '-3.13', 'spread': '1.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.22', 'ciLowerLimit': '-10.0', 'ciUpperLimit': '-2.43', 'statisticalMethod': 'mixed model for repeated measures (MMRM)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'TSS was measured using the MFSAF v4.0. The MFSAF v4.0 comprises 7 domains representing the 7 most relevant symptoms of MF identified through existing participant and clinician-based evidence: fatigue, night sweats, pruritus, abdominal discomfort, pain under the left ribs, early satiety, and bone pain. Participants scored each symptom domain using an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). The MFSAF TSS was calculated as the sum of scores of the 7 domains for a possible range of scores of 0 to 70, with a higher TSS corresponding to more severe symptoms. A reduction from Baseline corresponded to a lessening of MF symptoms. Baseline was the last assessment done before or on the day of first dose date. Change from Baseline was defined as the post-Baseline value minus Baseline value.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Splenic Response Rate (SRR) of >= 35% at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.31', 'groupId': 'OG000', 'lowerLimit': '15.48', 'upperLimit': '30.44'}, {'value': '3.08', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '10.68'}]}]}], 'analyses': [{'pValue': '0.0011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Cochran-Mantel-Haenszel', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.18', 'ciLowerLimit': '9.77', 'ciUpperLimit': '26.59', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': 'Splenic response rate (SRR) is defined as the percentage of participants who have reduction in spleen volume of \\>=35 % from Baseline at the end of Week 24. Baseline was the last assessment done before or on the day of first dose date.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Zero RBC Units Transfused Over 24-Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.38', 'groupId': 'OG000', 'lowerLimit': '27.20', 'upperLimit': '44.25'}, {'value': '16.92', 'groupId': 'OG001', 'lowerLimit': '8.76', 'upperLimit': '28.27'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Cochran-Mantel-Haenszel', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.20', 'ciLowerLimit': '7.99', 'ciUpperLimit': '26.40', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'Percentage of participants with zero RBC units transfused over 24-weeks were reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With <=4 RBC Units Transfused Over 24-weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.38', 'groupId': 'OG000', 'lowerLimit': '46.42', 'upperLimit': '64.10'}, {'value': '44.62', 'groupId': 'OG001', 'lowerLimit': '32.27', 'upperLimit': '57.47'}]}]}], 'analyses': [{'pValue': '0.1133', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Cochran-Mantel-Haenszel', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.62', 'ciLowerLimit': '-2.40', 'ciUpperLimit': '23.64', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'Percentage of participants with \\<=4 RBC units transfused over 24-weeks were reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}, {'type': 'SECONDARY', 'title': 'Duration of MFSAF TSS Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '286.00', 'groupId': 'OG000', 'lowerLimit': '286.00', 'upperLimit': '286.00'}, {'value': 'NA', 'comment': '\\<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to a maximum of 151 weeks', 'description': 'Duration of MFSAF TSS response is defined as the number of days from the start of the initial 28-day period in which a participant had a \\>= 50% reduction from Baseline TSS to the first day of the 7-day assessment that determines the mean TSS for the 28-day period during which the participants TSS equals or exceeds their Baseline value.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set. Only those participants with data available at specified time point were analyzed.'}, {'type': 'SECONDARY', 'title': 'Duration of TI Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': '\\<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': '\\<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to a maximum of 151 weeks', 'description': 'Duration of TI is defined as the number of days from (a) the first day of a 12-week period that satisfies the 12-week TI status definition, to (b) the first RBC transfusion or Hgb level \\< 8 g/dL (except in the case of clinically overt bleeding).', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set. Only those participants with data available at specified time point were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Cumulative Number of Whole Blood Units Transfused Over 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.55', 'spread': '8.413', 'groupId': 'OG000'}, {'value': '10.86', 'spread': '13.203', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.556', 'ciLowerLimit': '0.397', 'ciUpperLimit': '0.778', 'statisticalMethod': 'Anderson & Gill proportional means model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 24', 'description': 'Cumulative transfusion risk was calculated as the estimated mean cumulative number of whole blood units transfused during the study.', 'unitOfMeasure': 'Whole blood units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Transfusion Dependence (TD) Status at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.38', 'groupId': 'OG000', 'lowerLimit': '9.66', 'upperLimit': '22.76'}, {'value': '24.62', 'groupId': 'OG001', 'lowerLimit': '14.77', 'upperLimit': '36.87'}]}]}], 'analyses': [{'pValue': '0.1602', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified CMH', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.26', 'ciLowerLimit': '-20.18', 'ciUpperLimit': '3.66', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'TD status at Week 24 is defined as requirement of \\>=4 RBC units in an 8-week period immediately prior to the end of Week 24.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Hemoglobin Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'title': '>=1g/dL Increase', 'categories': [{'measurements': [{'value': '53.08', 'groupId': 'OG000', 'lowerLimit': '44.13', 'upperLimit': '61.88'}, {'value': '33.85', 'groupId': 'OG001', 'lowerLimit': '22.57', 'upperLimit': '46.65'}]}]}, {'title': '>=1.5g/dL Increase', 'categories': [{'measurements': [{'value': '40.00', 'groupId': 'OG000', 'lowerLimit': '31.51', 'upperLimit': '48.95'}, {'value': '23.08', 'groupId': 'OG001', 'lowerLimit': '13.53', 'upperLimit': '35.19'}]}]}, {'title': '>=2g/dL Increase', 'categories': [{'measurements': [{'value': '29.23', 'groupId': 'OG000', 'lowerLimit': '21.59', 'upperLimit': '37.85'}, {'value': '20.00', 'groupId': 'OG001', 'lowerLimit': '11.10', 'upperLimit': '31.77'}]}]}], 'analyses': [{'pValue': '0.0124', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified CMH', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.00', 'ciLowerLimit': '4.68', 'ciUpperLimit': '33.32', 'estimateComment': '\\>=1g/dL Increase in Hemoglobin response', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0282', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified CMH', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.68', 'ciLowerLimit': '2.47', 'ciUpperLimit': '28.90', 'estimateComment': '\\>=1.5g/dL Increase in Hemoglobin response', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2844', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified CMH', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.97', 'ciLowerLimit': '-5.41', 'ciUpperLimit': '19.35', 'estimateComment': '\\>=2g/dL Increase in Hemoglobin response', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': 'Hemoglobin responses are defined as increases of \\>= 1, \\>= 1.5, or \\>= 2 g/dL from Baseline in Hgb, as measured over a (rolling) period of at least 12 consecutive weeks falling entirely before the end of Week 24. Baseline was the last assessment done before or on the day of first dose date. Data has been reported for percentage of participants who had \\>= 1, \\>= 1.5, or \\>= 2 g/dL increase from Baseline in hemoglobin.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Baseline TD Participants With TI Status at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Participants were defined as having TD if they met both of the following requirements in the 8 weeks immediately before the end of Week 24: \\>= 4 red blood cell or whole blood units were transfused (except in the case of clinically overt bleeding), each in response to a hemoglobin assessment of \\<= 9.5 g/dL; and there were \\>= 2 hemoglobin assessments with \\>= 28 days between the earliest and latest hemoglobin assessments. TI status was defined as not requiring red blood cell transfusion (except in the case of clinically overt bleeding) for \\>= 12 weeks immediately prior to the end of Week 24, with hemoglobin levels \\>= 8 g/dL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Duration of TI in Baseline TD Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': '\\<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived', 'groupId': 'OG000', 'lowerLimit': '224.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': '\\<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.', 'groupId': 'OG001', 'lowerLimit': '196.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to a maximum of 151 weeks', 'description': 'Duration of TI is defined as the number of days from (a) the first day of a 12-week period that satisfies the 12-week TI status definition, to (b) the first RBC transfusion or Hgb level \\< 8 g/dL (except in the case of clinically overt bleeding).', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- up to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period', 'description': 'Participants were randomized to receive 200 mg of MMB orally QD and a DAN-placebo orally BID during the randomized 24-week double-blind treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period.'}], 'classes': [{'title': 'Any non-SAEs', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24', 'description': 'An adverse event (AE) is any untoward medical occurrence in a trial participant administered an investigational product(s), a comparator product, or an approved drug regardless of the causal relationship with treatment. An SAE is an AE that Results in death, life threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, results in a congenital anomaly/birth defect or any important medical events as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants in the ITT Analysis set who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- From Week 24 to a Maximum of 151 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD- Open-Label Extended Treatment Period', 'description': 'Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID to MMB 200 mg QD- Open-Label Extended Treatment Period', 'description': 'Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'title': 'Any non-SAEs', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 24 to a maximum of 151 weeks', 'description': 'An AE is any untoward medical occurrence in a trial participant administered an investigational product(s), a comparator product, or an approved drug regardless of the causal relationship with treatment. An SAE is an AE that Results in death, life threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, results in a congenital anomaly/birth defect or any important medical events as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '624.0', 'comment': '\\<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.', 'groupId': 'OG000', 'lowerLimit': '333.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': '\\<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived', 'groupId': 'OG001', 'lowerLimit': '309.00', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.6879', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.890', 'ciLowerLimit': '0.504', 'ciUpperLimit': '1.572', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to a maximum of 151 weeks', 'description': 'Overall survival is defined as the interval from the first study drug dosing date (or randomization date for participants who did not receive treatment) to death from any cause.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set. Values are presented based on the Kaplan-Meier analysis. All participants (overall population) were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Leukemia-free Survival (LFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '624.0', 'comment': '\\<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived', 'groupId': 'OG000', 'lowerLimit': '325.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': '\\<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.', 'groupId': 'OG001', 'lowerLimit': '284.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.4320', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.804', 'ciLowerLimit': '0.466', 'ciUpperLimit': '1.386', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to a maximum of 151 weeks', 'description': 'LFS is defined as the interval from first study drug dosing date (or randomization date for participants who did not receive treatment) to any evidence of leukemic transformation and/or death (from any cause).', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set. Values are presented based on the Kaplan-Meier analysis. All participants (overall population) were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease-related Fatigue as Assessed by MFSAF TSS v4.0 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.53', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0513', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.42', 'ciUpperLimit': '0.00', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The MFSAF v4.0 comprises 7 domains representing the 7 most relevant symptoms of MF identified through existing participant- and clinician-based evidence: fatigue, night sweats, pruritus, abdominal discomfort, pain under the left ribs, early satiety, and bone pain. Participants scored each symptom domain using an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Data has been reported for Disease-related Fatigue domain measured using an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable), higher score indicates worst outcome. An increase in score from Baseline indicated a worsening of fatigue and a decrease in score from Baseline indicated an improvement in fatigue. Baseline was the last assessment done before or on the day of first dose date. Change from Baseline was defined as the post-Baseline value minus Baseline value.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cancer-related Fatigue as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.34', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '-3.52', 'spread': '3.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.82', 'ciLowerLimit': '-19.15', 'ciUpperLimit': '-2.48', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The EORTC QLQ-C30 is comprised of 5 functional scales (physical, role, emotional, social, cognitive), eight single item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea), as well as sub-scales assessing global health/quality of life and financial impact. Most items use a 4-point Likert scale from "not at all" to "very much" and a one-week recall period with the exception of the final two items which use a 7 point scale response from "very poor" to "excellent". Scores were averaged and transformed to a 0-100 scale, with higher scores representing better functioning/quality of life. An increase in scores from Baseline indicated an improved functioning/quality of life, and a decrease in scores from Baseline indicated a worsened functioning/quality of life. Baseline was the last assessment done before or on the day of first dose date. Change from Baseline was defined as the post-Baseline value minus Baseline value.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physical Function Score as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10b at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'OG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.19', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '1.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3570', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '-1.49', 'ciUpperLimit': '4.11', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': "PROMIS Physical Function Short Form 10b consists of 14 questions; each with a 5-point response. PROMIS short form assesses self-reported capability of a participant rather than actual performance of physical activities. This includes functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back) as well as instrumental activities of daily living, such as running errands. Participants scored each response on a scale from 1 (unable to do) to 5 (without any difficulty, or not at all). Total possible range of scores was 14 to 70, with higher scores corresponding to a greater physical function ability. An increase in score from Baseline indicated an improvement in physical function ability and a decrease in score from Baseline indicated a reduction in physical function ability. Baseline was last assessment done before or on the day of first dose date. Change from Baseline was defined as post-Baseline value minus Baseline value.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set. Only those participants with data available at specified time points were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MMB 200 mg Once Daily (QD) + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'FG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 enrolled in an open-label extended treatment period. Participants switched to receive 200 mg of MMB orally QD during open-label extended treatment period. All participants elected to receive MMB as open-label treatment during the open-label extended treatment period.'}], 'periods': [{'title': 'Randomized DB TP (Up to Week 24)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Leukemic Transformation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open-Label Extended TP(Weeks 24 to 151)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '93 participants from Randomized Treatment Phase entered in Open-label Phase', 'groupId': 'FG000', 'numSubjects': '93'}, {'comment': 'Total 41 participants entered in Open-label Phase (36 out of 38 participants who completed Randomized Phase and 5 out of 27 who withdrew from Randomized Phase) as per Protocol defined criteria.', 'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Leukemic transformation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Continuing in MMB extension study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '27'}]}]}], 'recruitmentDetails': 'This study evaluated the activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic participants. This study consists of Randomized Double-blind (DB) Treatment Period (TP) and Open-label extended Treatment Period.', 'preAssignmentDetails': 'A total of 195 participants were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MMB 200 mg QD + Placebo', 'description': 'Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.'}, {'id': 'BG001', 'title': 'DAN 300 mg BID + Placebo', 'description': 'Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.85', 'spread': '8.24', 'groupId': 'BG000'}, {'value': '71.46', 'spread': '6.99', 'groupId': 'BG001'}, {'value': '70.38', 'spread': '7.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', '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': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '157', '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': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics were measured in the Intention-To-Treat (ITT) Analysis Set, which included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-18', 'size': 2467781, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-01T11:01', 'hasProtocol': True}, {'date': '2021-12-30', 'size': 1630710, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-01T11:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "During the 24 week randomized treatment phase of the study, participants, investigators and sponsor and relevant vendor personnel (with the exception of specified unblinded personnel, for example clinical supply) will remain blinded to the participant's treatment assignment and to aggregate data that may lead to inadvertent unblinding. Participants who continue treatment with momelotinib or danazol after Week 24 in the extended treatment phase will receive unblinded treatment."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2019-11-20', 'resultsFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2019-11-20', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-01', 'studyFirstPostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Symptom Score (TSS) Response Rate at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Myelofibrosis Symptom Assessment Form (MFSAF) TSS version (v) 4.0 response rate was defined as percentage of participants with a \\>= 50 percent (%) reduction from Baseline in mean MFSAF TSS over consecutive 28-day period immediately before end of Week 24. TSS response rate was measured using MFSAF v4.0. MFSAF v4.0 comprises 7 domains representing 7 most relevant symptoms of myelofibrosis (MF) identified through existing participant and clinician-based evidence: fatigue,night sweats,pruritus,abdominal discomfort,pain under left ribs,early satietyand bone pain. Participants scored each symptom domain using an 11-point numeric rating scale ranging from 0(absent) to 10(worst imaginable). The MFSAF TSS was calculated as sum of scores of 7 domains for a possible range of scores of 0 to 70, with a higher TSS corresponding to more severe symptoms. A reduction from Baseline corresponded to a lessening of MF symptoms. Baseline was the last assessment done before or on the day of first dose date.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Transfusion Independence (TI) at Week 24', 'timeFrame': 'Week 24', 'description': 'TI status was defined as not receiving red blood cell (RBC) or whole blood transfusion for \\>=12 weeks, with no hemoglobin (Hgb) level \\< 8 grams per deciliter (g/dL) during the same interval. Percentage of participants with TI have been presented.'}, {'measure': 'Splenic Response Rate (SRR) of >=25% at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Splenic response rate (SRR) is defined as the percentage of participants who have reduction in spleen volume of \\>=25% from Baseline at the end of Week 24. Baseline was the last assessment done before or on the day of first dose date.'}, {'measure': 'Change From Baseline in MFSAF TSS at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'TSS was measured using the MFSAF v4.0. The MFSAF v4.0 comprises 7 domains representing the 7 most relevant symptoms of MF identified through existing participant and clinician-based evidence: fatigue, night sweats, pruritus, abdominal discomfort, pain under the left ribs, early satiety, and bone pain. Participants scored each symptom domain using an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). The MFSAF TSS was calculated as the sum of scores of the 7 domains for a possible range of scores of 0 to 70, with a higher TSS corresponding to more severe symptoms. A reduction from Baseline corresponded to a lessening of MF symptoms. Baseline was the last assessment done before or on the day of first dose date. Change from Baseline was defined as the post-Baseline value minus Baseline value.'}, {'measure': 'Splenic Response Rate (SRR) of >= 35% at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Splenic response rate (SRR) is defined as the percentage of participants who have reduction in spleen volume of \\>=35 % from Baseline at the end of Week 24. Baseline was the last assessment done before or on the day of first dose date.'}, {'measure': 'Percentage of Participants With Zero RBC Units Transfused Over 24-Weeks', 'timeFrame': 'Up to 24 weeks', 'description': 'Percentage of participants with zero RBC units transfused over 24-weeks were reported.'}, {'measure': 'Percentage of Participants With <=4 RBC Units Transfused Over 24-weeks', 'timeFrame': 'Up to 24 weeks', 'description': 'Percentage of participants with \\<=4 RBC units transfused over 24-weeks were reported.'}, {'measure': 'Duration of MFSAF TSS Response', 'timeFrame': 'Up to a maximum of 151 weeks', 'description': 'Duration of MFSAF TSS response is defined as the number of days from the start of the initial 28-day period in which a participant had a \\>= 50% reduction from Baseline TSS to the first day of the 7-day assessment that determines the mean TSS for the 28-day period during which the participants TSS equals or exceeds their Baseline value.'}, {'measure': 'Duration of TI Response', 'timeFrame': 'Up to a maximum of 151 weeks', 'description': 'Duration of TI is defined as the number of days from (a) the first day of a 12-week period that satisfies the 12-week TI status definition, to (b) the first RBC transfusion or Hgb level \\< 8 g/dL (except in the case of clinically overt bleeding).'}, {'measure': 'Mean Cumulative Number of Whole Blood Units Transfused Over 24 Weeks', 'timeFrame': 'Up to Week 24', 'description': 'Cumulative transfusion risk was calculated as the estimated mean cumulative number of whole blood units transfused during the study.'}, {'measure': 'Percentage of Participants With Transfusion Dependence (TD) Status at Week 24', 'timeFrame': 'Week 24', 'description': 'TD status at Week 24 is defined as requirement of \\>=4 RBC units in an 8-week period immediately prior to the end of Week 24.'}, {'measure': 'Percentage of Participants With a Hemoglobin Response', 'timeFrame': 'Baseline and Week 24', 'description': 'Hemoglobin responses are defined as increases of \\>= 1, \\>= 1.5, or \\>= 2 g/dL from Baseline in Hgb, as measured over a (rolling) period of at least 12 consecutive weeks falling entirely before the end of Week 24. Baseline was the last assessment done before or on the day of first dose date. Data has been reported for percentage of participants who had \\>= 1, \\>= 1.5, or \\>= 2 g/dL increase from Baseline in hemoglobin.'}, {'measure': 'Number of Baseline TD Participants With TI Status at Week 24', 'timeFrame': 'Week 24', 'description': 'Participants were defined as having TD if they met both of the following requirements in the 8 weeks immediately before the end of Week 24: \\>= 4 red blood cell or whole blood units were transfused (except in the case of clinically overt bleeding), each in response to a hemoglobin assessment of \\<= 9.5 g/dL; and there were \\>= 2 hemoglobin assessments with \\>= 28 days between the earliest and latest hemoglobin assessments. TI status was defined as not requiring red blood cell transfusion (except in the case of clinically overt bleeding) for \\>= 12 weeks immediately prior to the end of Week 24, with hemoglobin levels \\>= 8 g/dL.'}, {'measure': 'Duration of TI in Baseline TD Participants', 'timeFrame': 'Up to a maximum of 151 weeks', 'description': 'Duration of TI is defined as the number of days from (a) the first day of a 12-week period that satisfies the 12-week TI status definition, to (b) the first RBC transfusion or Hgb level \\< 8 g/dL (except in the case of clinically overt bleeding).'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- up to Week 24', 'timeFrame': 'Up to Week 24', 'description': 'An adverse event (AE) is any untoward medical occurrence in a trial participant administered an investigational product(s), a comparator product, or an approved drug regardless of the causal relationship with treatment. An SAE is an AE that Results in death, life threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, results in a congenital anomaly/birth defect or any important medical events as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)- From Week 24 to a Maximum of 151 Weeks', 'timeFrame': 'From Week 24 to a maximum of 151 weeks', 'description': 'An AE is any untoward medical occurrence in a trial participant administered an investigational product(s), a comparator product, or an approved drug regardless of the causal relationship with treatment. An SAE is an AE that Results in death, life threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, results in a congenital anomaly/birth defect or any important medical events as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to a maximum of 151 weeks', 'description': 'Overall survival is defined as the interval from the first study drug dosing date (or randomization date for participants who did not receive treatment) to death from any cause.'}, {'measure': 'Leukemia-free Survival (LFS)', 'timeFrame': 'Up to a maximum of 151 weeks', 'description': 'LFS is defined as the interval from first study drug dosing date (or randomization date for participants who did not receive treatment) to any evidence of leukemic transformation and/or death (from any cause).'}, {'measure': 'Change From Baseline in Disease-related Fatigue as Assessed by MFSAF TSS v4.0 at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'The MFSAF v4.0 comprises 7 domains representing the 7 most relevant symptoms of MF identified through existing participant- and clinician-based evidence: fatigue, night sweats, pruritus, abdominal discomfort, pain under the left ribs, early satiety, and bone pain. Participants scored each symptom domain using an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Data has been reported for Disease-related Fatigue domain measured using an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable), higher score indicates worst outcome. An increase in score from Baseline indicated a worsening of fatigue and a decrease in score from Baseline indicated an improvement in fatigue. Baseline was the last assessment done before or on the day of first dose date. Change from Baseline was defined as the post-Baseline value minus Baseline value.'}, {'measure': 'Change From Baseline in Cancer-related Fatigue as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'The EORTC QLQ-C30 is comprised of 5 functional scales (physical, role, emotional, social, cognitive), eight single item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea), as well as sub-scales assessing global health/quality of life and financial impact. Most items use a 4-point Likert scale from "not at all" to "very much" and a one-week recall period with the exception of the final two items which use a 7 point scale response from "very poor" to "excellent". Scores were averaged and transformed to a 0-100 scale, with higher scores representing better functioning/quality of life. An increase in scores from Baseline indicated an improved functioning/quality of life, and a decrease in scores from Baseline indicated a worsened functioning/quality of life. Baseline was the last assessment done before or on the day of first dose date. Change from Baseline was defined as the post-Baseline value minus Baseline value.'}, {'measure': 'Change From Baseline in Physical Function Score as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10b at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': "PROMIS Physical Function Short Form 10b consists of 14 questions; each with a 5-point response. PROMIS short form assesses self-reported capability of a participant rather than actual performance of physical activities. This includes functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back) as well as instrumental activities of daily living, such as running errands. Participants scored each response on a scale from 1 (unable to do) to 5 (without any difficulty, or not at all). Total possible range of scores was 14 to 70, with higher scores corresponding to a greater physical function ability. An increase in score from Baseline indicated an improvement in physical function ability and a decrease in score from Baseline indicated a reduction in physical function ability. Baseline was last assessment done before or on the day of first dose date. Change from Baseline was defined as post-Baseline value minus Baseline value."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myelofibrosis', 'JAK inhibitor', 'Danazol', 'Momelotinib', 'Functional Iron deficiency', 'Activin receptor type 1', 'Anemia', 'Transfusion', 'Hepcidin', 'Myeloproliferative Disorders', 'Bone Marrow Diseases', 'Hematologic Diseases'], 'conditions': ['Primary Myelofibrosis', 'Post-polycythemia Vera Myelofibrosis', 'Post-essential Thrombocythemia Myelofibrosis']}, 'referencesModule': {'references': [{'pmid': '40691344', 'type': 'DERIVED', 'citation': 'Yoon SS, Chen CC, Lee SE, Chang H, Cheong JW, Hou HA, Lee WS, Lim SN, Moon JH, Ong KH, Dai Y, Liu C, Kawashima J, Goh YT. Efficacy and safety of momelotinib in Janus kinase inhibitor-experienced Asian patients with myelofibrosis and anemia. Int J Hematol. 2025 Nov;122(5):660-670. doi: 10.1007/s12185-025-04037-6. Epub 2025 Jul 21.'}, {'pmid': '40535755', 'type': 'DERIVED', 'citation': "Mesa RA, Talpaz M, Mazerolle F, Gorsh B, M'Hari M, Regnault A, Ellis C, Wang Z, Purser M, Liu T, Strouse B, Patnaik D. Time Without Transfusion Reliance (TWiTR): Integrating Survival Quality Into Myelofibrosis Treatment Strategies Based on the Phase 3 SIMPLIFY-1, SIMPLIFY-2, and MOMENTUM Trials. EJHaem. 2025 Jun 18;6(3):e70075. doi: 10.1002/jha2.70075. eCollection 2025 Jun."}, {'pmid': '39516087', 'type': 'DERIVED', 'citation': 'Harrison CN, Mesa R, Talpaz M, Gupta V, Gerds AT, Perkins A, Goh YT, Fox ML, McLornan D, Palmer J, Foltz L, Vannucchi A, Koschmieder S, Passamonti F, Lee SE, Ellis C, Strouse B, Gonzalez Carreras FJ, Oh ST. Longitudinal Assessment of Transfusion Intensity in Patients With JAK Inhibitor-Naive or -Experienced Myelofibrosis Treated With Momelotinib. Clin Lymphoma Myeloma Leuk. 2025 Mar;25(3):199-211. doi: 10.1016/j.clml.2024.10.001. Epub 2024 Oct 16.'}, {'pmid': '37517413', 'type': 'DERIVED', 'citation': 'Gerds AT, Verstovsek S, Vannucchi AM, Al-Ali HK, Lavie D, Kuykendall AT, Grosicki S, Iurlo A, Goh YT, Lazaroiu MC, Egyed M, Fox ML, McLornan D, Perkins A, Yoon SS, Gupta V, Kiladjian JJ, Granacher N, Lee SE, Ocroteala L, Passamonti F, Harrison CN, Oh S, Klencke BJ, Yu J, Donahue R, Kawashima J, Mesa R. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis previously treated with a JAK inhibitor (MOMENTUM): an updated analysis of an international, double-blind, randomised phase 3 study. Lancet Haematol. 2023 Sep;10(9):e735-e746. doi: 10.1016/S2352-3026(23)00174-6. Epub 2023 Jul 27.'}, {'pmid': '37042865', 'type': 'DERIVED', 'citation': 'Verstovsek S, Mesa R, Gupta V, Lavie D, Dubruille V, Cambier N, Platzbecker U, Hus M, Xicoy B, Oh ST, Kiladjian JJ, Vannucchi AM, Gerds A, Egyed M, Mayer J, Sacha T, Kawashima J, Morris M, Huang M, Harrison C. Momelotinib long-term safety and survival in myelofibrosis: integrated analysis of phase 3 randomized controlled trials. Blood Adv. 2023 Jul 25;7(14):3582-3591. doi: 10.1182/bloodadvances.2022009311.'}, {'pmid': '36709073', 'type': 'DERIVED', 'citation': 'Verstovsek S, Gerds AT, Vannucchi AM, Al-Ali HK, Lavie D, Kuykendall AT, Grosicki S, Iurlo A, Goh YT, Lazaroiu MC, Egyed M, Fox ML, McLornan D, Perkins A, Yoon SS, Gupta V, Kiladjian JJ, Granacher N, Lee SE, Ocroteala L, Passamonti F, Harrison CN, Klencke BJ, Ro S, Donahue R, Kawashima J, Mesa R; MOMENTUM Study Investigators. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study. Lancet. 2023 Jan 28;401(10373):269-280. doi: 10.1016/S0140-6736(22)02036-0.'}]}, 'descriptionModule': {'briefSummary': 'MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom (UK) and United States (US).\n\nParticipants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of \\>= 10 at screening, and be anemic with hemoglobin (Hgb) \\< 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization.\n\nParticipants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB.\n\nParticipants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically confirmed symptomatic splenic progression. Participants randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF.', 'detailedDescription': 'MOMENTUM Contact Email: GSKClinicalSupportHD@gsk.com'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>= 18 years.\n* Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post- polycythemia vera/essential thrombocythemia (PV/ET) MF in accordance with the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT criteria).\n* Symptomatic, defined as a TSS of \\>= 10 units assessed by a single MFSAF v4.0 assessment during Screening prior to Baseline period (Day BL1).\n* Anemic, defined as a Hgb \\< 10 g/dL in Screening/Baseline period.\n* Previously treated with an approved JAK inhibitor for PMF or Post-PV/ET MF for \\>= 90 days, or \\>= 28 days if JAK inhibitor therapy is complicated by RBC transfusion requirement of \\>= 4 units in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma.\n* Baseline splenomegaly, defined as having a palpable spleen at \\>= 5 centimeter (cm), below the left costal margin, or with volume \\>= 450 cubic centimeter (cm\\^3) on imaging (ultrasound, magnetic resonance imaging \\[MRI\\] or computed tomography \\[CT\\] are acceptable), assessed during Screening at any point prior to Randomization.\n* High risk, intermediate-2, or intermediate-1 risk MF as defined by Dynamic International Prognostic Scoring System (DIPSS), or DIPSS-plus.\n* No allogeneic stem cell transplant planned.\n* Acceptable laboratory assessments:\n\n 1. Absolute neutrophil count (ANC) \\>= 0.75 × 10\\^9/Liter (L).\n 2. Platelet count (PLT) \\>= 25 × 10\\^9/L (without requirement for platelet transfusion).\n 3. Peripheral blast count \\< 10%.\n 4. Alanine aminotransferase/ glutamic-oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/ serum glutamic-pyruvic transaminase (ALT/SGPT) \\<= 3 × Upper Limit Normal (ULN) (\\<= 5 × ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days).\n 5. Calculated creatinine clearance (CCr) \\>= 30 milliliter per minute (mL/min) according to Cockcroft-Gault.\n 6. Direct bilirubin \\<= 2.0 × ULN.\n\nExclusion Criteria:\n\n* Use of the following treatments within the time periods noted:\n\n 1. Prior momelotinib treatment at any time.\n 2. Approved JAK inhibitor therapy (eg, fedratinib or ruxolitinib) within 1 week prior to the first day of Baseline.\n 3. Active anti-MF therapy within 1 week prior to the first day of Baseline.\n 4. Potent Cytochrome P450 3A4 (CYP3A4) inducers within 1 week prior to Randomization.\n 5. Investigational agent (including investigational JAK inhibitors) within 4 weeks prior to Randomization.\n 6. Erythropoiesis stimulating agent (ESA) within 4 weeks prior to Randomization.\n 7. Danazol within 3 months prior to Randomization.\n 8. Splenic irradiation within 3 months prior to Randomization.\n 9. Current treatment with simvastatin, atorvastatin, lovastatin or rosuvastatin.\n* History of prostate cancer, with the exception of localized prostate cancer that has been treated surgically or by radiotherapy with curative intent and presumed cured.\n* Prostate specific antigen (PSA) \\> 4 nanograms per milliliter (ng/mL).\n* Unsuitable for spleen volume measurements due to prior splenectomy or unwilling or unable to undergo an MRI scan or CT scan for spleen volume measurement per protocol requirements.\n* Any of the following (criteria a - k):\n\n 1. Uncontrolled intercurrent illness including, but not limited to: active uncontrolled infection (participants receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the trial).\n 2. Significant active or chronic bleeding event \\>= Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, within 4 weeks prior to Randomization.\n 3. Unstable angina pectoris within 6 months prior to Randomization.\n 4. Symptomatic congestive heart failure within 6 months prior to Randomization.\n 5. Uncontrolled cardiac arrhythmia within 6 months prior to Randomization.\n 6. QT Interval Corrected Using Fridericia's Formula (QTcF) interval \\> 500 millisecond (msec), unless attributed to bundle branch block.\n 7. Current progressive thrombosis despite treatment.\n 8. History of porphyria.\n 9. Child-Pugh score \\>= 10.\n 10. Psychiatric illness, social situation, or any other condition that would limit compliance with trial requirements or may interfere with the interpretation of study results, as judged by investigator or sponsor.\n 11. Inability or unwillingness to comply with the protocol restrictions on MF therapy and other medications prior to and during study treatment.\n* Participants with a prior or concurrent malignancy, whose natural history or treatment has a significant potential to interfere with the safety or efficacy assessment of the investigational regimen.\n* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding or thalassemia.\n* Known positive status for human immunodeficiency viruses (HIV).\n* Chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier (testing required for hepatitis B and C).\n* Unresolved non-hematologic toxicities from prior therapies that are \\> Grade 1 per CTCAE v5.0.\n* Presence of peripheral neuropathy \\>= Grade 2 per CTCAE v5.0.\n* Women who are already pregnant or lactating. Additional inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT04173494', 'briefTitle': 'A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sierra Oncology LLC - a GSK company'}, 'officialTitle': 'A Randomized, Double-blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) Versus Danazol (DAN) in Symptomatic, Anemic Subjects With Primary Myelofibrosis (PMF), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis Who Were Previously Treated With JAK Inhibitor Therapy', 'orgStudyIdInfo': {'id': 'SRA-MMB-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Momelotinib', 'description': 'Participants will receive momelotinib plus placebo to match danazol', 'interventionNames': ['Drug: Momelotinib', 'Drug: Placebo to match danazol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Danazol', 'description': 'Participants will receive danazol plus placebo to match momelotinib', 'interventionNames': ['Drug: Danazol', 'Drug: Placebo to match momelotinib']}], 'interventions': [{'name': 'Momelotinib', 'type': 'DRUG', 'otherNames': ['MMB, GS-0387, CYT387'], 'description': 'Momelotinib tablets will be self-administered orally once daily', 'armGroupLabels': ['Momelotinib']}, {'name': 'Placebo to match danazol', 'type': 'DRUG', 'description': 'Danazol placebo capsules will be self-administered orally twice daily', 'armGroupLabels': ['Momelotinib']}, {'name': 'Danazol', 'type': 'DRUG', 'otherNames': ['Danocrine'], 'description': 'Danazol capsules will be self-administered orally twice daily', 'armGroupLabels': ['Danazol']}, {'name': 'Placebo to match momelotinib', 'type': 'DRUG', 'description': 'Momelotinib placebo tablets will be self-administered orally once daily', 'armGroupLabels': ['Danazol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Hospital - Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92614', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Irvine Center for Clinical Research', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '91011', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'American Institute of Research - Whittier', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital Anschutz Cancer Pavilion', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20057', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60008', 'city': 'Rolling Meadows', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwest Oncology & Hematology - Rolling Meadows', 'geoPoint': {'lat': 42.08419, 'lon': -88.01313}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine in Saint Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center - Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44011', 'city': 'Avon', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic - Richard E. 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Notre Dame', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '8000', 'city': 'Bruges', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '2060', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Ziekenhuis Netwerk Antwerpen Stuivenberg', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': 'B-4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'University Hospital St. Ivan Rilski', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital For Active Treatment Aleksandrovska', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1756', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'National Specialized Hospital for Active Treatment of Haematologic Diseases', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "Saint Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II Health Sciences Centre - 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