Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-14 @ 3:02 PM
Study NCT ID:
NCT04603495
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2020-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '+1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study treatment up to the cut-off date for the interim analysis (31-Aug-2023), approximately 28 months', 'description': 'Adverse Events were reported that had a start date on or after the first dose of the pelabresib/placebo and before 30 days after the last dose of pelabresib/placebo or before the start of alternative (off study) treatment for MF, whichever occured first. In addition, Serious Adverse Events, including deaths, that were reported at any time after 30 days after the last dose of pelabresib/placebo are presented.', 'eventGroups': [{'id': 'EG000', 'title': 'Pelabresib + Ruxolitinib (Experimental Arm)', 'description': 'Pelabresib 125 mg orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle', 'otherNumAtRisk': 212, 'deathsNumAtRisk': 212, 'otherNumAffected': 201, 'seriousNumAtRisk': 212, 'deathsNumAffected': 11, 'seriousNumAffected': 63}, {'id': 'EG001', 'title': 'Placebo + Ruxolitinib (Control Arm)', 'description': 'Matching placebo orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle', 'otherNumAtRisk': 214, 'deathsNumAtRisk': 214, 'otherNumAffected': 204, 'seriousNumAtRisk': 214, 'deathsNumAffected': 10, 'seriousNumAffected': 63}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 116}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 50}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Platelet Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 34}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blood Creatinine Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Left Ventricular Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sinus Node Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thyroid Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chronic Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastric Varices Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oesophageal Varices Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Varices Oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Drug Withdrawal Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sudden Cardiac Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bile Duct Stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 7}, {'groupId': 'EG001', 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{'term': 'Covid-19 Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haematoma Muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 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Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Squamous Cell Carcinoma Of The Tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Uterine Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemorrhage Intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Post Herpetic Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Embolism Arterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Shock Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Splenic Response by Central Radiology Reads at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pelabresib + Ruxolitinib (Experimental Arm)', 'description': 'Pelabresib 125 mg orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}, {'id': 'OG001', 'title': 'Placebo + Ruxolitinib (Control Arm)', 'description': 'Matching placebo orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.4', 'ciLowerLimit': '21.6', 'ciUpperLimit': '39.3', 'estimateComment': 'The proportion difference = experimental group (Pela + RUX) - control group (placebo + RUX).', 'groupDescription': 'Splenic Response Rate at Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'CMH 95% CI adjusted by strata; Mehrotra-Railkar test used if Breslow-Day significant; DIPSS High merged with Int-2 due to low counts.', 'nonInferiorityComment': 'The response rate between the 2 treatment groups was compared using CMH test.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Splenic response was characterized by a reduction of at least 35% in spleen volume from baseline (SVR35), as determined by magnetic resonance imaging (MRI) or computerized tomography (CT), and evaluated through a blinded central radiology review at Week 24.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Analysis Set'}, {'type': 'SECONDARY', 'title': 'Key Secondary: Absolute Change From Baseline in Total Symptom Score (TSS) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pelabresib + Ruxolitinib (Experimental Arm)', 'description': 'Pelabresib 125 mg orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}, {'id': 'OG001', 'title': 'Placebo + Ruxolitinib (Control Arm)', 'description': 'Matching placebo orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.99', 'spread': '1.028', 'groupId': 'OG000'}, {'value': '-14.05', 'spread': '0.986', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0545', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.94', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.009', 'groupDescription': 'Absolute Change from Baseline in Total Symptom Score (TSS) at Week 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The Total Symptom Score (TSS) at Week 24, compared to baseline, was measured using the Myelofibrosis Symptom Assessment Form v4.0. This score represented the sum of seven individual symptom items, each rated on a 0-10 scale, resulting in a possible total daily score ranging from 0 to 70. A higher TSS reflected a greater disease burden and therefore a worse outcome. The baseline TSS was calculated as the average of non-missing daily total symptom scores over the seven-day period preceding the day of randomization. The TSS for each treatment week was determined as the average of non-missing daily total symptom scores for that week. However, if fewer than four daily scores were available for a given week, the weekly TSS was considered missing.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Analysis Set'}, {'type': 'SECONDARY', 'title': 'Key Secondary: Number of Participants With TSS50 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pelabresib + Ruxolitinib (Experimental Arm)', 'description': 'Pelabresib 125 mg orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}, {'id': 'OG001', 'title': 'Placebo + Ruxolitinib (Control Arm)', 'description': 'Matching placebo orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.216', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.0', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '15.5', 'estimateComment': 'Proportion Difference = Experimental Group (Pela + RUX) - Control Group (placebo + RUX).', 'groupDescription': 'Percentage of TSS50 at Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'CMH 95% CI adjusted by strata; Mehrotra-Railkar test used if Breslow-Day significant; DIPSS High merged with Int-2 due to low counts.', 'nonInferiorityComment': 'The response rate between the 2 treatment groups was compared using CMH test.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'The probability of a TSS response at Week 24 was estimated by calculating the TSS response rate, defined as the percentage of patients who achieved a TSS50 response at Week 24 in each of the two treatment groups. The Total Symptom Score (TSS) response was defined as a ≥50% reduction from baseline in TSS, as measured by the Myelofibrosis Symptom Assessment Form v4.0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Symptom Score (TSS) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pelabresib + Ruxolitinib (Experimental Arm)', 'description': 'Pelabresib 125 mg orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}, {'id': 'OG001', 'title': 'Placebo + Ruxolitinib (Control Arm)', 'description': 'Matching placebo orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.3', 'groupId': 'OG000', 'lowerLimit': '-56.6', 'upperLimit': '-44.0'}, {'value': '-45.9', 'groupId': 'OG001', 'lowerLimit': '-51.8', 'upperLimit': '-40.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "Percent Change From Baseline in Total Symptom Score (TSS) at Week 24 measured the change in a patient's symptoms after 24 weeks of treatment, relative to baseline. A negative value indicates symptom improvement, and a reduction of ≥50% is typically considered a meaningful clinical response.", 'unitOfMeasure': 'Percent change from baseline to Week 24', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improvement From Baseline in Bone Marrow Fibrosis of at Least 1 Grade at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pelabresib + Ruxolitinib (Experimental Arm)', 'description': 'Pelabresib 125 mg orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}, {'id': 'OG001', 'title': 'Placebo + Ruxolitinib (Control Arm)', 'description': 'Matching placebo orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.63', 'ciLowerLimit': '0.52', 'ciUpperLimit': '14.73', 'estimateComment': 'Proportion Difference = Experimental Group (Pela + RUX) - Control Group (placebo + RUX).', 'groupDescription': '≥1 Grade improvement From Baseline in Bone Marrow Fibrosis at Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'CMH 95% CI adjusted across the strata including baseline DIPSS, platelet count, and spleen volume.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 24', 'description': 'Improvement in bone marrow fibrosis by at least 1 grade, as assessed by central read compared to baseline, was analyzed by treatment group and overall. The improvement in bone marrow fibrosis grade was defined as a decrease by at least 1 grade in bone marrow fibrosis grade when compared to baseline, where a grade of MF-3 was the most severe, and MF-0 was the least severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Analysis Set: Only participants with available data at the specified time point were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Splenic Response by Central Radiology Reads at Week 48', 'timeFrame': 'Week 48', 'description': 'Splenic response is characterized by a reduction of at least 35% in spleen volume from baseline (SVR35), as determined by magnetic resonance imaging (MRI) or computerized tomography (CT), and evaluated through a blinded central radiology review at Week 48.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TSS50 Response at Week 48', 'timeFrame': 'Week 48', 'description': 'The probability of a TSS response at Week 48 is estimated by calculating the TSS response rate, defined as the percentage of patients who achieve a TSS50 response at Week 48 in each of the two treatment groups. The Total Symptom Score (TSS) response is defined as a ≥50% reduction from baseline in TSS, as measured by the Myelofibrosis Symptom Assessment Form v4.0.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Total Symptom Score (TSS) at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'The Total Symptom Score (TSS) at Week 48, compared to baseline, is measured using the Myelofibrosis Symptom Assessment Form v4.0. This score represents the sum of seven individual symptom items, each rated on a 0-10 scale, resulting in a possible total daily score ranging from 0 to 70. A higher TSS reflects a greater disease burden and therefore a worse outcome. The baseline TSS is calculated as the average of non-missing daily total symptom scores over the seven-day period preceding the day of randomization. The TSS for each treatment week is determined as the average of non-missing daily total symptom scores for that week. However, if fewer than four daily scores are available for a given week, the weekly TSS is considered missing.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Rate of Red Blood Cell (RBC) Transfusion Over First 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pelabresib + Ruxolitinib (Experimental Arm)', 'description': 'Pelabresib 125 mg orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}, {'id': 'OG001', 'title': 'Placebo + Ruxolitinib (Control Arm)', 'description': 'Matching placebo orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '1.359', 'groupId': 'OG000', 'lowerLimit': '0.982', 'upperLimit': '1.736'}, {'value': '1.014', 'groupId': 'OG001', 'lowerLimit': '0.840', 'upperLimit': '1.188'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'The rate of RBC transfusions was defined as the average number of RBC units transfused per patient month (4 weeks) during the first 24 weeks of treatment. The average number of RBC units per patient-month was calculated by dividing the total (ie, for all patients) number of RBC units in the whole exposure time by the sum of patient-months.', 'unitOfMeasure': 'RBC units transfused/patient-months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Transitioned From Red Blood Cell (RBC) Transfusion Dependence to Transfusion Independence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pelabresib + Ruxolitinib (Experimental Arm)', 'description': 'Pelabresib 125 mg orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}, {'id': 'OG001', 'title': 'Placebo + Ruxolitinib (Control Arm)', 'description': 'Matching placebo orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 12-week baseline period prior to dosing to any 12-week period post baseline, up to 24 weeks', 'description': 'Transfusion dependence (TD) was defined as having received ≥6 units of RBCs during the 12-week baseline period prior to dosing and Transfusion independence (TI) was defined as the absence of RBC transfusions during any continuous 12-week period of the double-blind treatment phase.\n\nThe conversion from TD to TI was evaluated and defined as the proportion of patients who transitioned from transfusion dependence to transfusion independence. Patients who remained in the double-blind treatment period and had not received any RBC transfusions during the most recent 12 weeks were considered responders. Patients who discontinued from the double-blind treatment before Week 12 were classified as non-responders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Analysis Set'}, {'type': 'SECONDARY', 'title': 'Category Change From Baseline of Patient Global Impression of Change (PGIC) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pelabresib + Ruxolitinib (Experimental Arm)', 'description': 'Pelabresib 125 mg orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}, {'id': 'OG001', 'title': 'Placebo + Ruxolitinib (Control Arm)', 'description': 'Matching placebo orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}], 'classes': [{'categories': [{'title': 'Very much improved', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Much improved', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}, {'title': 'Minimally improved', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Minimally worse', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Much worse', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very much worse', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 24', 'description': 'The Patient Global Impression of Change (PGIC) was a single-item measure of the patient\'s perceived change in MF symptoms since starting treatment. Patients responded to: "Since beginning this study treatment, your myelofibrosis symptoms were: (1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, (7) Very much worse."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Analysis Set - Only participants with evaluable data at the pre-specified time points'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'timeFrame': 'Through study completion, an average of 6 years', 'description': 'Progression-Free Survival (PFS), defined as the time from randomization until documented progression, or until death from any cause for patients without documented progression', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'timeFrame': 'Through study completion, an average of 6 years', 'description': 'OS, defined as the time from randomization until death from any cause', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Transformation to Blast Phase (AML)', 'timeFrame': 'Through study completion, an average of 6 years', 'description': 'Patients are categorized as having transformed to Acute Myelogenous Leukemia (AML) when the peripheral blood blast percentage increases to ≥20% and this elevation persists for at least two weeks, or when leukemic transformation is confirmed through disease status assessment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Through study completion, an average of 6 years', 'description': 'A treatment-emergent adverse event (TEAE) for the double-blind treatment period is defined as an AE that has a start date on or after the first dose of the pelabresib/placebo and before 30 days after the last dose of pelabresib/placebo or before the start of alternative (off-study) treatment for MF, whichever occurs first. If the AE has a start date before the date of first dose but increases in severity after first dose and before 30 days post last dose will be considered a TEAE as well. An AE that occurs after the administration of the first dose of open-label pelabresib treatment will be considered treatment-emergent for the crossover treatment period. However, a TEAE for the crossover treatment period that occurs within 30 days after the last dose of pelabresib/placebo will be considered treatment emergent for the double-blind treatment period as well.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameters for Pelabresib: Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t)', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days', 'description': 'Pharmacokinetic (PK) parameters will be calculated based on Pelabresib plasma concentrations and actual sampling time points.\n\nAUC0-t will be listed and summarized using descriptive statistics.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameters for Pelabresib: Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax)', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days', 'description': 'Pharmacokinetic (PK) parameters will be calculated based on Pelabresib plasma concentrations and actual sampling time points.\n\nAUC0-t will be listed and summarized using descriptive statistics. Tmax will be listed and summarized using descriptive statistics.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameters for Pelabresib: Maximum (Peak) Plasma Drug Concentration (Cmax)', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days', 'description': 'Pharmacokinetic (PK) parameters will be calculated based on Pelabresib plasma concentrations and actual sampling time points.\n\nAUC0-t will be listed and summarized using descriptive statistics. Cmax will be listed and summarized using descriptive statistics.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameters for Pelabresib: Effective Half-Life (T1/2)', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days', 'description': 'Pharmacokinetic (PK) parameters will be calculated based on Pelabresib plasma concentrations and actual sampling time points.\n\nT1/2 will be listed and summarized using descriptive statistics.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameters for Pelabresib: Apparent Volume of Distribution After Non-intravenous Administration (Vd/F)', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days', 'description': 'Pharmacokinetic (PK) parameters will be calculated based on Pelabresib plasma concentrations and actual sampling time points.\n\nVd/F will be listed and summarized using descriptive statistics.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameters for Pelabresib: Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F)', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days', 'description': 'Pharmacokinetic (PK) parameters will be calculated based on Pelabresib plasma concentrations and actual sampling time points.\n\nCL/F will be listed and summarized using descriptive statistics.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Ruxolitinib Plasma Concentrations in the Presence or Absence of Pelabresib', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days', 'description': 'Blood samples (approximately 4 mL each) will be collected at the time points specified in the Schedule of Assessments (SOA) to determine plasma concentrations of Ruxolitinib plasma concentrations in the presence or absence of Pelabresib', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Duration of the Splenic Response', 'timeFrame': 'Through study completion, an average of 6 years', 'description': 'Duration of splenic response, defined as the time from onset of splenic response until the time at which the patient has a \\<35% decrease from baseline in spleen volume and a \\>25% increase from nadir, as confirmed by the central review) or death, whichever comes first', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Modified Total Symptom Score (mTSS) Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pelabresib + Ruxolitinib (Experimental Arm)', 'description': 'Pelabresib 125 mg orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}, {'id': 'OG001', 'title': 'Placebo + Ruxolitinib (Control Arm)', 'description': 'Matching placebo orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.107', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.8', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '17.2', 'estimateComment': 'The proportion difference = experimental group (Pela + RUX) - control group (placebo + RUX). Wald 95% CIs were applied.', 'groupDescription': 'Modified Total Symptom Score (mTSS) Response at Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'CMH 95% CI adjusted by strata; Mehrotra-Railkar test used if Breslow-Day significant; DIPSS High merged with Int-2 due to low counts.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'The modified TSS (mTSS) was defined as TSS without the fatigue sub-domain and with a total scale of 60 points versus 70 points for TSS. Patients were classified as responders if the percentage of change from baseline in mTSS was ≤ -50% at Week 24.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Analysis Set'}, {'type': 'SECONDARY', 'title': 'Duration of the TSS50 Response', 'timeFrame': 'Through study completion, an average of 6 years', 'description': 'Duration of TSS response, defined as the time from onset of TSS50 response until the time at which the patient has a \\<50% reduction in TSS from baseline and an increase of ≥25% from nadir', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pelabresib + Ruxolitinib (Experimental Arm)', 'description': 'Pelabresib 125 mg orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}, {'id': 'FG001', 'title': 'Placebo + Ruxolitinib (Control Arm)', 'description': 'Matching placebo orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Intent-to-Treat (ITT) Analysis Set: all randomized patients, for whom a randomization number has been assigned.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '216'}]}, {'type': 'Modified Intent-to-Treat (mITT) Analysis Set', 'comment': 'All randomized patients who have received at least 1 dose of any study drug(s)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '214'}]}, {'type': 'Safety Analysis Set', 'comment': 'A subset of the ITT population that includes all randomized patients who were administered at least one dose of study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '214'}]}, {'type': 'Per-Protocol Set (PP Set)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '194'}]}, {'type': 'Pharmacokinetic (PK) Analysis Set', 'comment': 'All patients in the Safety Set who received placebo/pelabresib + ruxolitinib treatment and had plasma samples drawn and tested for study drug concentrations.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '211'}]}, {'type': 'Biomarker Analysis Set', 'comment': 'All patients in the Safety Set who received any treatment component and had evaluable biomarker data collected.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '214'}]}, {'type': 'Ongoing on Double-blind Treatment', 'comment': 'Ongoing on double-blind treatment at the time of Primary Completion Date', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'Discontinued Double-blind Treatment', 'comment': 'Discontinued double-blind treatment at the time of Primary Completion Date', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'On PFS/OS Follow-up', 'comment': 'On Progression-Free Survival (PFS)/Overall Survival (OS) follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'comment': 'Completed Week 24 double-blind treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '193'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '23'}]}]}], 'recruitmentDetails': 'A total of 135 centers enrolled patients in the study in Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Malaysia, Netherlands, Poland, South Korea, Spain, Taiwan, Thailand, Turkey, United Kingdom, and United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '430', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pelabresib + Ruxolitinib (Experimental Arm)', 'description': 'Pelabresib 125 mg orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}, {'id': 'BG001', 'title': 'Placebo + Ruxolitinib (Control Arm)', 'description': 'Matching placebo orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'spread': '11.84', 'groupId': 'BG000'}, {'value': '64.8', 'spread': '11.08', 'groupId': 'BG001'}, {'value': '64.7', 'spread': '11.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '393', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '77', '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': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '323', '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': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dynamic International Prognostic Scoring System (DIPSS) risk category', 'classes': [{'categories': [{'title': 'Intermediate-1', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}, {'title': 'Intermediate-2', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}, {'title': 'High', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Dynamic International Prognostic Scoring System (DIPSS) is used to predict survival in PMF patients, calculated from five variables: a. Age \\>65: 1 point b. Leukocyte count \\>25 × 10\\^9/L: 1 point c. Hemoglobin \\<10 g/dL: 2 points d. Circulating blast cells ≥1%: 1 point e. Constitutional symptoms\\*: 1 point The total DIPSS score categorizes patients into four risk groups, with lower scores indicating better outcomes and longer survival: • 0 points: low risk • 1-2 points: intermediate-1 risk • 3-4 points: intermediate-2 risk • 5-6 points: high risk', 'unitOfMeasure': 'Participants'}, {'title': 'Platelet count', 'classes': [{'categories': [{'title': '>200 × 10^9 cells/L', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}]}, {'title': '100-200 × 10^9 cells/L', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': '<100 × 10^9 cells/L', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hemoglobin', 'classes': [{'categories': [{'title': '>10 g/dL', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}]}, {'title': '≤10 g/dL', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'categories': [{'title': 'Primary Myelofibrosis (PMF)', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}, {'title': 'Post-Polycythemia Vera Myelofibrosis (PPV-MF)', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Post-Essential Thrombocythemia Myelofibrosis (PET-MF)', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Spleen volume from central reads', 'classes': [{'categories': [{'measurements': [{'value': '1522.43', 'spread': '950.18', 'groupId': 'BG000'}, {'value': '1539.28', 'spread': '920.78', 'groupId': 'BG001'}, {'value': '1530.90', 'spread': '934.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm^3', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Total Symptom Score (TSS)', 'classes': [{'categories': [{'measurements': [{'value': '28.26', 'spread': '12.70', 'groupId': 'BG000'}, {'value': '27.36', 'spread': '12.30', 'groupId': 'BG001'}, {'value': '27.81', 'spread': '12.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline TSS = Averaged daily TSS from the 7-day period prior to randomization (Day -7 to Day -1). Daily TSS is a 24-hour recall format of the MFSAF v4.0, which equals the sum of the 7 individual item responses on the 0-10 scale, with a possible total daily score ranging from 0 to 70. For each individual question, the response scale is 0 (Absent) to 10 (Worst Imaginable).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-Treat Population. All randomized patients. This is the primary population for all efficacy endpoints. All analyses using this population will be based on the treatment assigned by the Interactive Response Technology (IRT) system.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-04', 'size': 1982527, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-14T13:29', 'hasProtocol': True}, {'date': '2023-10-26', 'size': 1047667, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-14T14:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study has a double-blind design in which patients and investigators are blinded to study drug; study drugs will be packaged identically. All patients will be randomly assigned to either treatment group in a 1:1 ratio. The blind should only be broken in the case of emergency.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 430}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2020-10-20', 'resultsFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-10-25', 'studyFirstPostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Splenic Response by Central Radiology Reads at Week 24', 'timeFrame': 'Week 24', 'description': 'Splenic response was characterized by a reduction of at least 35% in spleen volume from baseline (SVR35), as determined by magnetic resonance imaging (MRI) or computerized tomography (CT), and evaluated through a blinded central radiology review at Week 24.'}], 'secondaryOutcomes': [{'measure': 'Key Secondary: Absolute Change From Baseline in Total Symptom Score (TSS) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The Total Symptom Score (TSS) at Week 24, compared to baseline, was measured using the Myelofibrosis Symptom Assessment Form v4.0. This score represented the sum of seven individual symptom items, each rated on a 0-10 scale, resulting in a possible total daily score ranging from 0 to 70. A higher TSS reflected a greater disease burden and therefore a worse outcome. The baseline TSS was calculated as the average of non-missing daily total symptom scores over the seven-day period preceding the day of randomization. The TSS for each treatment week was determined as the average of non-missing daily total symptom scores for that week. However, if fewer than four daily scores were available for a given week, the weekly TSS was considered missing.'}, {'measure': 'Key Secondary: Number of Participants With TSS50 Response at Week 24', 'timeFrame': 'Week 24', 'description': 'The probability of a TSS response at Week 24 was estimated by calculating the TSS response rate, defined as the percentage of patients who achieved a TSS50 response at Week 24 in each of the two treatment groups. The Total Symptom Score (TSS) response was defined as a ≥50% reduction from baseline in TSS, as measured by the Myelofibrosis Symptom Assessment Form v4.0.'}, {'measure': 'Percent Change From Baseline in Total Symptom Score (TSS) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': "Percent Change From Baseline in Total Symptom Score (TSS) at Week 24 measured the change in a patient's symptoms after 24 weeks of treatment, relative to baseline. A negative value indicates symptom improvement, and a reduction of ≥50% is typically considered a meaningful clinical response."}, {'measure': 'Number of Participants With Improvement From Baseline in Bone Marrow Fibrosis of at Least 1 Grade at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Improvement in bone marrow fibrosis by at least 1 grade, as assessed by central read compared to baseline, was analyzed by treatment group and overall. The improvement in bone marrow fibrosis grade was defined as a decrease by at least 1 grade in bone marrow fibrosis grade when compared to baseline, where a grade of MF-3 was the most severe, and MF-0 was the least severe.'}, {'measure': 'Number of Participants With Splenic Response by Central Radiology Reads at Week 48', 'timeFrame': 'Week 48', 'description': 'Splenic response is characterized by a reduction of at least 35% in spleen volume from baseline (SVR35), as determined by magnetic resonance imaging (MRI) or computerized tomography (CT), and evaluated through a blinded central radiology review at Week 48.'}, {'measure': 'Number of Participants With TSS50 Response at Week 48', 'timeFrame': 'Week 48', 'description': 'The probability of a TSS response at Week 48 is estimated by calculating the TSS response rate, defined as the percentage of patients who achieve a TSS50 response at Week 48 in each of the two treatment groups. The Total Symptom Score (TSS) response is defined as a ≥50% reduction from baseline in TSS, as measured by the Myelofibrosis Symptom Assessment Form v4.0.'}, {'measure': 'Absolute Change From Baseline in Total Symptom Score (TSS) at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'The Total Symptom Score (TSS) at Week 48, compared to baseline, is measured using the Myelofibrosis Symptom Assessment Form v4.0. This score represents the sum of seven individual symptom items, each rated on a 0-10 scale, resulting in a possible total daily score ranging from 0 to 70. A higher TSS reflects a greater disease burden and therefore a worse outcome. The baseline TSS is calculated as the average of non-missing daily total symptom scores over the seven-day period preceding the day of randomization. The TSS for each treatment week is determined as the average of non-missing daily total symptom scores for that week. However, if fewer than four daily scores are available for a given week, the weekly TSS is considered missing.'}, {'measure': 'Rate of Red Blood Cell (RBC) Transfusion Over First 24 Weeks of Treatment', 'timeFrame': 'Week 24', 'description': 'The rate of RBC transfusions was defined as the average number of RBC units transfused per patient month (4 weeks) during the first 24 weeks of treatment. The average number of RBC units per patient-month was calculated by dividing the total (ie, for all patients) number of RBC units in the whole exposure time by the sum of patient-months.'}, {'measure': 'Number of Participants Who Transitioned From Red Blood Cell (RBC) Transfusion Dependence to Transfusion Independence', 'timeFrame': 'From 12-week baseline period prior to dosing to any 12-week period post baseline, up to 24 weeks', 'description': 'Transfusion dependence (TD) was defined as having received ≥6 units of RBCs during the 12-week baseline period prior to dosing and Transfusion independence (TI) was defined as the absence of RBC transfusions during any continuous 12-week period of the double-blind treatment phase.\n\nThe conversion from TD to TI was evaluated and defined as the proportion of patients who transitioned from transfusion dependence to transfusion independence. Patients who remained in the double-blind treatment period and had not received any RBC transfusions during the most recent 12 weeks were considered responders. Patients who discontinued from the double-blind treatment before Week 12 were classified as non-responders.'}, {'measure': 'Category Change From Baseline of Patient Global Impression of Change (PGIC) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The Patient Global Impression of Change (PGIC) was a single-item measure of the patient\'s perceived change in MF symptoms since starting treatment. Patients responded to: "Since beginning this study treatment, your myelofibrosis symptoms were: (1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, (7) Very much worse."'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Through study completion, an average of 6 years', 'description': 'Progression-Free Survival (PFS), defined as the time from randomization until documented progression, or until death from any cause for patients without documented progression'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Through study completion, an average of 6 years', 'description': 'OS, defined as the time from randomization until death from any cause'}, {'measure': 'Proportion of Patients With Transformation to Blast Phase (AML)', 'timeFrame': 'Through study completion, an average of 6 years', 'description': 'Patients are categorized as having transformed to Acute Myelogenous Leukemia (AML) when the peripheral blood blast percentage increases to ≥20% and this elevation persists for at least two weeks, or when leukemic transformation is confirmed through disease status assessment.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Through study completion, an average of 6 years', 'description': 'A treatment-emergent adverse event (TEAE) for the double-blind treatment period is defined as an AE that has a start date on or after the first dose of the pelabresib/placebo and before 30 days after the last dose of pelabresib/placebo or before the start of alternative (off-study) treatment for MF, whichever occurs first. If the AE has a start date before the date of first dose but increases in severity after first dose and before 30 days post last dose will be considered a TEAE as well. An AE that occurs after the administration of the first dose of open-label pelabresib treatment will be considered treatment-emergent for the crossover treatment period. However, a TEAE for the crossover treatment period that occurs within 30 days after the last dose of pelabresib/placebo will be considered treatment emergent for the double-blind treatment period as well.'}, {'measure': 'Pharmacokinetic (PK) Parameters for Pelabresib: Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t)', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days', 'description': 'Pharmacokinetic (PK) parameters will be calculated based on Pelabresib plasma concentrations and actual sampling time points.\n\nAUC0-t will be listed and summarized using descriptive statistics.'}, {'measure': 'Pharmacokinetic (PK) Parameters for Pelabresib: Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax)', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days', 'description': 'Pharmacokinetic (PK) parameters will be calculated based on Pelabresib plasma concentrations and actual sampling time points.\n\nAUC0-t will be listed and summarized using descriptive statistics. Tmax will be listed and summarized using descriptive statistics.'}, {'measure': 'Pharmacokinetic (PK) Parameters for Pelabresib: Maximum (Peak) Plasma Drug Concentration (Cmax)', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days', 'description': 'Pharmacokinetic (PK) parameters will be calculated based on Pelabresib plasma concentrations and actual sampling time points.\n\nAUC0-t will be listed and summarized using descriptive statistics. Cmax will be listed and summarized using descriptive statistics.'}, {'measure': 'Pharmacokinetic (PK) Parameters for Pelabresib: Effective Half-Life (T1/2)', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days', 'description': 'Pharmacokinetic (PK) parameters will be calculated based on Pelabresib plasma concentrations and actual sampling time points.\n\nT1/2 will be listed and summarized using descriptive statistics.'}, {'measure': 'Pharmacokinetic (PK) Parameters for Pelabresib: Apparent Volume of Distribution After Non-intravenous Administration (Vd/F)', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days', 'description': 'Pharmacokinetic (PK) parameters will be calculated based on Pelabresib plasma concentrations and actual sampling time points.\n\nVd/F will be listed and summarized using descriptive statistics.'}, {'measure': 'Pharmacokinetic (PK) Parameters for Pelabresib: Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F)', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days', 'description': 'Pharmacokinetic (PK) parameters will be calculated based on Pelabresib plasma concentrations and actual sampling time points.\n\nCL/F will be listed and summarized using descriptive statistics.'}, {'measure': 'Ruxolitinib Plasma Concentrations in the Presence or Absence of Pelabresib', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 14 and Cycle 9 Day 1: Predose, 30 minutes to 1 hour post-dose, 3 to 4.5 hours post-dose. Cycle 3 and Cycle 7 Day 1: Predose, 5 minutes post ECG assessment. 1 Cycle = 21 days', 'description': 'Blood samples (approximately 4 mL each) will be collected at the time points specified in the Schedule of Assessments (SOA) to determine plasma concentrations of Ruxolitinib plasma concentrations in the presence or absence of Pelabresib'}, {'measure': 'Duration of the Splenic Response', 'timeFrame': 'Through study completion, an average of 6 years', 'description': 'Duration of splenic response, defined as the time from onset of splenic response until the time at which the patient has a \\<35% decrease from baseline in spleen volume and a \\>25% increase from nadir, as confirmed by the central review) or death, whichever comes first'}, {'measure': 'Number of Participants With Modified Total Symptom Score (mTSS) Response at Week 24', 'timeFrame': 'Week 24', 'description': 'The modified TSS (mTSS) was defined as TSS without the fatigue sub-domain and with a total scale of 60 points versus 70 points for TSS. Patients were classified as responders if the percentage of change from baseline in mTSS was ≤ -50% at Week 24.'}, {'measure': 'Duration of the TSS50 Response', 'timeFrame': 'Through study completion, an average of 6 years', 'description': 'Duration of TSS response, defined as the time from onset of TSS50 response until the time at which the patient has a \\<50% reduction in TSS from baseline and an increase of ≥25% from nadir'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pelabresib', 'Ruxolitinib'], 'conditions': ['Myelofibrosis', 'Primary Myelofibrosis', 'Post-polycythemia Vera Myelofibrosis', 'Post-essential Thrombocythemia Myelofibrosis']}, 'referencesModule': {'references': [{'pmid': '35950489', 'type': 'RESULT', 'citation': 'Harrison CN, Gupta VK, Gerds AT, Rampal R, Verstovsek S, Talpaz M, Kiladjian JJ, Mesa R, Kuykendall AT, Vannucchi AM, Palandri F, Grosicki S, Devos T, Jourdan E, Wondergem MJ, Al-Ali HK, Buxhofer-Ausch V, Alvarez-Larran A, Patriarca A, Kremyanskaya M, Mead AJ, Akhani S, Sheikine Y, Colak G, Mascarenhas J. Phase III MANIFEST-2: pelabresib + ruxolitinib vs placebo + ruxolitinib in JAK inhibitor treatment-naive myelofibrosis. Future Oncol. 2022 Sep;18(27):2987-2997. doi: 10.2217/fon-2022-0484. Epub 2022 Aug 11.'}, {'pmid': '40065169', 'type': 'RESULT', 'citation': 'Rampal RK, Grosicki S, Chraniuk D, Abruzzese E, Bose P, Gerds AT, Vannucchi AM, Palandri F, Lee SE, Gupta V, Lucchesi A, Oh ST, Kuykendall AT, Patriarca A, Alvarez-Larran A, Mesa R, Kiladjian JJ, Talpaz M, Scandura JM, Lavie D, Harris M, Kays SK, Li Q, Boxhammer R, Brown B, Jegg AM, Harrison CN, Mascarenhas J. Pelabresib plus ruxolitinib for JAK inhibitor-naive myelofibrosis: a randomized phase 3 trial. Nat Med. 2025 May;31(5):1531-1538. doi: 10.1038/s41591-025-03572-3. Epub 2025 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia)\n* Adequate hematologic, renal, and hepatic function\n* Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0\n* Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system\n* Spleen volume of ≥ 450 cm\\^3\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n\nExclusion Criteria:\n\n* Splenectomy or splenic irradiation in the previous 6 months\n* Chronic or active conditions and/or concomitant medication use that would prohibit treatment\n* Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm'}, 'identificationModule': {'nctId': 'NCT04603495', 'acronym': 'MANIFEST-2', 'briefTitle': 'Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Active-Control Study of Pelabresib (CPI-0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients', 'orgStudyIdInfo': {'id': 'CDAK539A12301'}, 'secondaryIdInfos': [{'id': '2023-507954-34-00', 'type': 'REGISTRY', 'domain': 'EU CT Number'}, {'id': 'CPI 0610-04', 'type': 'OTHER', 'domain': 'Constellation Pharmaceuticals'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pelabresib + ruxolitinib', 'description': 'Pelabresib monohydrate tablets + ruxolitinib phosphate tablets', 'interventionNames': ['Drug: Pelabresib', 'Drug: Ruxolitinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + ruxolitinib', 'description': 'Matching placebo tablets + ruxolitinib phosphate tablets', 'interventionNames': ['Drug: Ruxolitinib', 'Drug: Placebo']}], 'interventions': [{'name': 'Pelabresib', 'type': 'DRUG', 'description': 'Double-blind treatment (pelabresib or matching placebo) will be administered daily for 14 consecutive days followed by a 7-day break, which is considered 1 cycle of treatment (1 cycle = 21 days).\n\nPelabresib is a small molecule inhibitor of BET proteins with a novel mechanism of action and potential for disease-modifying effects in MF.', 'armGroupLabels': ['Pelabresib + ruxolitinib']}, {'name': 'Ruxolitinib', 'type': 'DRUG', 'description': 'Ruxolitinib is a JAK inhibitor and a current, approved treatment option for MF.', 'armGroupLabels': ['Pelabresib + ruxolitinib', 'Placebo + ruxolitinib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets are designed to match pelabresib tablets. Each placebo tablet contains no active pharmaceutical ingredient and is visibly identical to experimental drug in size, shape, and packaging. Placebo dosing follows the same dosing conventions as pelabresib.', 'armGroupLabels': ['Placebo + ruxolitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-3300', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Franciscan Health/Indiana blood and Marrow Transplantation', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Cancer Institute, St. Matthews Campus', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College- New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center - 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