Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-02-23 @ 2:21 AM
Study NCT ID:
NCT03112603
Status:
COMPLETED
Last Update Posted:
2025-08-12
First Post:
2017-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)
Sponsor:
Organization:
Raw JSON
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'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D019908', 'term': 'Proto-Oncogene Proteins c-raf'}, {'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D015649', 'term': 'Pentostatin'}, {'id': 'D000068877', 'term': 'Imatinib Mesylate'}, {'id': 'C551803', 'term': 'ibrutinib'}], 'ancestors': [{'id': 'D011701', 'term': 'PUVA Therapy'}, {'id': 'D014467', 'term': 'Ultraviolet Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D048490', 'term': 'raf Kinases'}, {'id': 'D020930', 'term': 'MAP Kinase Kinase Kinases'}, {'id': 'D017346', 'term': 'Protein Serine-Threonine Kinases'}, {'id': 'D011494', 'term': 'Protein Kinases'}, {'id': 'D017853', 'term': 'Phosphotransferases (Alcohol Group Acceptor)'}, {'id': 'D010770', 'term': 'Phosphotransferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011518', 'term': 'Proto-Oncogene Proteins'}, {'id': 'D015513', 'term': 'Oncogene Proteins'}, {'id': 'D009363', 'term': 'Neoplasm Proteins'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D003070', 'term': 'Coformycin'}, {'id': 'D005573', 'term': 'Formycins'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@incyte.com', 'phone': '1.855.463.3463', 'title': 'Incyte Corporation', 'organization': 'Call Center'}, 'certainAgreement': {'otherDetails': 'Clinical Study Agreement', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'from Baseline to LPLV (approximately 5 years)', 'description': 'Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.', 'eventGroups': [{'id': 'EG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).', 'otherNumAtRisk': 165, 'deathsNumAtRisk': 165, 'otherNumAffected': 158, 'seriousNumAtRisk': 165, 'deathsNumAffected': 37, 'seriousNumAffected': 86}, {'id': 'EG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.", 'otherNumAtRisk': 158, 'deathsNumAtRisk': 158, 'otherNumAffected': 132, 'seriousNumAtRisk': 158, 'deathsNumAffected': 40, 'seriousNumAffected': 71}, {'id': 'EG002', 'title': 'Ruxolitinib Cross-Over Period', 'description': 'Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 62, 'seriousNumAtRisk': 70, 'deathsNumAffected': 10, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'BK virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cytomegalovirus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Fibrin D dimer increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 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(25.1)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vulvovaginal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Alveolar proteinosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Obliterative bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Respiratory acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Toxic epidermal necrolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Loss of personal independence in daily activities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Poor peripheral circulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'categories': [{'measurements': [{'value': '49.7', 'groupId': 'OG000', 'lowerLimit': '41.8', 'upperLimit': '57.6'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '19.1', 'upperLimit': '33.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.99', 'ciLowerLimit': '1.86', 'ciUpperLimit': '4.80', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 7 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'ORR was defined as the percentage of participants in each arm demonstrating a complete response (CR) or partial response (PR) based on chronic GvHD (cGvHD) disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all participants to whom study treatment was assigned by randomization. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020).'}, {'type': 'SECONDARY', 'title': 'Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '31.5'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '16.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Cycle 7 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'To assess improvement of symptoms based on the total symptom score (TSS); a responder was defined as having achieved a clinically relevant reduction from Baseline of the TSS. The scale consists of 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). Participants reported their level of symptom "bother" over the previous month on a 5-point likert scale: not at all, slightly, moderately, quite a bit, or extremely. Subscale scores and the summary score range from 0 to 100, with a higher score indicating worse symptoms.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020).'}, {'type': 'SECONDARY', 'title': 'Rate of Failure-free Survival (FFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median FFS time was not reached due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '18.6', 'upperLimit': 'NA'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '6.5'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.370', 'ciLowerLimit': '0.268', 'ciUpperLimit': '0.510', 'pValueComment': 'The p-value was derived from a 1-sided stratified log-rank test.', 'estimateComment': 'The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to when the last participant reached Cycle 7 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020).'}, {'type': 'SECONDARY', 'title': 'Rate of FFS at Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'categories': [{'measurements': [{'value': '38.4', 'comment': 'The upper limit of the confidence interval was not estimable due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': 'NA'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '6.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.361', 'ciLowerLimit': '0.268', 'ciUpperLimit': '0.485', 'estimateComment': 'The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to Last Participant Last Visit (LPLV) (approximately 5 years)', 'description': 'Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Best Overall Response (BOR) at Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '82.6'}, {'value': '60.4', 'groupId': 'OG001', 'lowerLimit': '52.4', 'upperLimit': '67.9'}]}]}], 'analyses': [{'pValue': '0.0011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.17', 'ciLowerLimit': '1.34', 'ciUpperLimit': '3.52', 'pValueComment': 'The one-sided p-value was calculated using a stratified Cochran-Mantel-Haenszel test.', 'estimateComment': 'The odds ratio and 95% confidence interval (CI) were calculated using a stratified Cochran-Mantel-Haenszel test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'up to Cycle 7 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD). Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. This analysis was based on the primary cutoff date (May 2020).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020).'}, {'type': 'SECONDARY', 'title': 'BOR During Cross-over Treatment With Ruxolitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib Cross-Over Period', 'description': 'Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000', 'lowerLimit': '70.3', 'upperLimit': '89.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from Crossover Cycle 1 Day 1 to any time point up to and including Crossover Cycle 7 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD). Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-over Analysis Set'}, {'type': 'SECONDARY', 'title': 'ORR at the End of Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000', 'lowerLimit': '46.6', 'upperLimit': '62.3'}, {'value': '31.1', 'groupId': 'OG001', 'lowerLimit': '24.1', 'upperLimit': '38.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.77', 'ciLowerLimit': '1.75', 'ciUpperLimit': '4.39', 'pValueComment': 'The one-sided p-value was calculated using a stratified Cochran-Mantel-Haenszel (CMH) test.', 'estimateComment': 'The odds ratio and 95% CI were calculated using a stratified CMH test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 4 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'ORR was defined as the percentage of participants in each arm demonstrating a CR or PR based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Duration of Response Through Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median duration of response was not reached due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '11.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from first response to LPLV (approximately 5 years)', 'description': 'DOR was defined as the time from first response until cGvHD progression, death, or the date of change/addition of systemic therapies for cGvHD and as assessed for responders only. Response was based on cGvHD disease assessments (National Institutes of Health consensus criteria). Duration of response was evaluated in participants who achieved a CR or PR at or before Cycle 7 Day 1. The analysis included a larger number of participants than the number of participants who achieved CR or PR at Cycle 7 Day 1 (82 ruxolitinib and 42 BAT) because the analysis took into account not only those participants who achieved CR or PR at Cycle 7 Day 1, but also participants who achieved CR or PR before Cycle 7 Day 1 but who may have lost their response at Cycle 7 Day 1. For this reason, the number of participants in this analysis does not align with the best overall response (BOR) at Cycle 7 Day 1. This analysis was based on the cutoff date upon study completion (December 2022).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Duration of response was evaluated in participants who achieved a CR or PR at or before Cycle 7 Day 1.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and upper and lower limits of the confidence interval were not estimable because too few participants died.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and upper limit of the confidence interval were not estimable because too few participants died.', 'groupId': 'OG001', 'lowerLimit': '41.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.2396', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.851', 'ciLowerLimit': '0.544', 'ciUpperLimit': '1.331', 'pValueComment': 'The p-value was derived from a 1-sided stratified log-rank test.', 'estimateComment': 'The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'from the date of randomization to the date of death due to any cause up to LPLV (approximately 5 years)', 'description': 'Overall survival was defined as the time from the date of randomization to the date of death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Non-relapse Mortality (NRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.45', 'groupId': 'OG000', 'lowerLimit': '2.68', 'upperLimit': '9.67'}, {'value': '4.44', 'groupId': 'OG001', 'lowerLimit': '1.96', 'upperLimit': '8.48'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.13', 'groupId': 'OG000', 'lowerLimit': '5.34', 'upperLimit': '14.15'}, {'value': '6.43', 'groupId': 'OG001', 'lowerLimit': '3.28', 'upperLimit': '11.03'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.30', 'groupId': 'OG000', 'lowerLimit': '10.26', 'upperLimit': '21.26'}, {'value': '15.12', 'groupId': 'OG001', 'lowerLimit': '9.94', 'upperLimit': '21.30'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.93', 'groupId': 'OG000', 'lowerLimit': '10.78', 'upperLimit': '21.98'}, {'value': '16.48', 'groupId': 'OG001', 'lowerLimit': '11.06', 'upperLimit': '22.84'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.83', 'groupId': 'OG000', 'lowerLimit': '12.37', 'upperLimit': '24.10'}, {'value': '19.22', 'groupId': 'OG001', 'lowerLimit': '13.36', 'upperLimit': '25.90'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.83', 'groupId': 'OG000', 'lowerLimit': '12.37', 'upperLimit': '24.10'}, {'value': '19.22', 'groupId': 'OG001', 'lowerLimit': '13.94', 'upperLimit': '26.67'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.83', 'groupId': 'OG000', 'lowerLimit': '12.37', 'upperLimit': '24.10'}, {'value': '22.0', 'groupId': 'OG001', 'lowerLimit': '15.73', 'upperLimit': '28.96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 3, 6, 12, 18, 24, 30, and 36', 'description': 'Defined as the cumulative incidence rate from competing risk analysis for NRM from the date of randomization to the date of death not preceded by underlying disease relapse/recurrence.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'title': 'Day 15 to ≤ Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 to ≤ Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}, {'value': '33.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 43 to ≤ Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}, {'value': '41.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 to ≤ Day 70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.7', 'groupId': 'OG000'}, {'value': '47.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 71 to ≤ Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000'}, {'value': '51.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 to ≤ Day 98', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.5', 'groupId': 'OG000'}, {'value': '54.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 99 to ≤ Day 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000'}, {'value': '60.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 to ≤ Day 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.2', 'groupId': 'OG000'}, {'value': '66.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 127 to ≤ Day 140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.8', 'groupId': 'OG000'}, {'value': '68.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 to ≤ Day 154', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}, {'value': '68.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 155 to ≤ Day 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.6', 'groupId': 'OG000'}, {'value': '71.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 to ≤ Day 182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.9', 'groupId': 'OG000'}, {'value': '88.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from Day 15 up to Day 182', 'description': 'All corticosteroid dosages prescribed to the participant and all dose changes during the study were to be recorded for assessment of participants with a ≥ 50% reduction in daily corticosteroid dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set: all participants who received at least one dose of study treatment. Participants were to have been analyzed according to the study treatment received, where treatment received was defined as the randomized treatment if the participant took at least one dose of that treatment or the first treatment received if the randomized treatment was never received. Six participants in the BAT arm discontinued before receiving the first dose. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Successfully Tapered Off of All Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'title': 'Day 1 to ≤ Day 28', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 to ≤ Day 56', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 to ≤ Day 84', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 to ≤ Day 112', 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 to ≤ Day 140', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '12.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 to ≤ Day 168', 'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000'}, {'value': '16.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 to ≤ Day 179', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}, {'value': '15.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to Day 179', 'description': 'All corticosteroid dosages prescribed to the participant and all dose changes during the study were to be recorded for assessment of participants who successfully tapered off of all corticosteroids. Participants who completely tapered off corticosteroids refer to those who permanently discontinued steroids as per the dose administration panel and who did not restart steroids in the same interval. Participants who were tapered off and continued follow-up were also counted as being tapered off with 0 dose in subsequent intervals until they discontinued from the main treatment period or restarted steroid treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Malignancy Relapse/Recurrence (MR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'title': '0 to < 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.92', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '5.12'}, {'value': '1.31', 'groupId': 'OG001', 'lowerLimit': '0.26', 'upperLimit': '4.27'}]}]}, {'title': '3 to < 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.22', 'groupId': 'OG000', 'lowerLimit': '1.20', 'upperLimit': '6.93'}, {'value': '2.65', 'groupId': 'OG001', 'lowerLimit': '0.87', 'upperLimit': '6.21'}]}]}, {'title': '6 to < 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.18', 'groupId': 'OG000', 'lowerLimit': '2.42', 'upperLimit': '9.49'}, {'value': '6.08', 'groupId': 'OG001', 'lowerLimit': '2.98', 'upperLimit': '10.73'}]}]}, {'title': '12 to < 18 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.82', 'groupId': 'OG000', 'lowerLimit': '4.25', 'upperLimit': '12.77'}, {'value': '6.08', 'groupId': 'OG001', 'lowerLimit': '2.98', 'upperLimit': '10.73'}]}]}, {'title': '18 to < 24 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.48', 'groupId': 'OG000', 'lowerLimit': '4.74', 'upperLimit': '13.57'}, {'value': '6.08', 'groupId': 'OG001', 'lowerLimit': '2.98', 'upperLimit': '10.73'}]}]}, {'title': '24 to <30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.48', 'groupId': 'OG000', 'lowerLimit': '4.74', 'upperLimit': '13.57'}, {'value': '6.78', 'groupId': 'OG001', 'lowerLimit': '3.46', 'upperLimit': '11.62'}]}]}, {'title': '30 to <36 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.48', 'groupId': 'OG000', 'lowerLimit': '4.74', 'upperLimit': '13.57'}, {'value': '7.50', 'groupId': 'OG001', 'lowerLimit': '3.96', 'upperLimit': '12.52'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 3, 6, 12, 18, 24, 30, and 36', 'description': 'Defined as the cumulative incidence rate from competing risk analysis of MR from the date of randomization to hematologic malignancy relapse/recurrence.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Cumulative incidence was calculated for participants with underlying hematologic malignant disease. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.32', 'spread': '12.191', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '14.949', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.62', 'spread': '14.452', 'groupId': 'OG000'}, {'value': '-1.82', 'spread': '15.849', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.98', 'spread': '15.888', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '16.147', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.25', 'spread': '14.577', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '18.903', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.91', 'spread': '14.562', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '14.766', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.14', 'spread': '14.669', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '16.811', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.32', 'spread': '16.815', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '17.635', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.26', 'spread': '19.296', 'groupId': 'OG000'}, {'value': '3.74', 'spread': '18.059', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.07', 'spread': '18.220', 'groupId': 'OG000'}, {'value': '7.58', 'spread': '17.063', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.10', 'spread': '19.440', 'groupId': 'OG000'}, {'value': '8.19', 'spread': '17.993', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.24', 'spread': '19.485', 'groupId': 'OG000'}, {'value': '3.68', 'spread': '17.378', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.90', 'spread': '19.662', 'groupId': 'OG000'}, {'value': '7.84', 'spread': '18.561', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 27 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.23', 'spread': '18.880', 'groupId': 'OG000'}, {'value': '5.10', 'spread': '18.885', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.53', 'spread': '20.314', 'groupId': 'OG000'}, {'value': '5.75', 'spread': '21.037', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 33 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.17', 'spread': '20.330', 'groupId': 'OG000'}, {'value': '5.67', 'spread': '22.573', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 36 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.72', 'spread': '18.710', 'groupId': 'OG000'}, {'value': '4.77', 'spread': '24.186', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 39 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.65', 'spread': '21.669', 'groupId': 'OG000'}, {'value': '6.64', 'spread': '22.384', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The FACT-BMT is a 50-item self-report questionnaire that measures the effect of a therapy on domains including physical, functional, social/family, and emotional well-being, together with additional concerns relevant for bone marrow transplantation participants. The questions were based on a 5-point Likert scale, where 0 corresponds to "not at all" and 4 corresponds to "very much." The higher the final score, the better the quality of life. The FACT-BMT total score ranges from 0 to 148.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-5D-5L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.214', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.163', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.221', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.259', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.196', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.192', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.210', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.243', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.230', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.186', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.234', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.225', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.228', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.166', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.187', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.158', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.250', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.140', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.299', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.110', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.268', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.222', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.272', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.164', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 27 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.299', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.182', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.261', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.159', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 33 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.282', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.186', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 36 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.231', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.216', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 39 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.255', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.214', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'The EQ-5D-5L is a descriptive classification consisting of five dimensions of health: mobility, self-care, usual activities, anxiety/depression, and pain/discomfort. The five-level version (no problems, slight problems, moderate problems, severe problems, and extreme problems) uses a 5-point Likert scale, with 1 being no problems and 5 being extreme problems.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}, {'id': 'OG002', 'title': 'Ruxolitinib Cross-Over Period', 'description': 'Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from Baseline to LPLV (approximately 5 years)', 'description': "Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occurred after the participant's signed informed consent was obtained. Abnormal laboratory values or test results occurring after informed consent constituted adverse events only if they induced clinical signs or symptoms, were considered clinically significant, required therapy (e.g., hematologic abnormality that required transfusion or hematological stem cell support), or required changes in study medication(s). TEAEs were defined as those AEs that started or worsened during the on-treatment period (either randomized or cross-over period).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set. Six participants in the BAT arm discontinued before receiving the first dose.'}, {'type': 'SECONDARY', 'title': 'Cmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '167', 'spread': '39.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '215', 'spread': '48.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose', 'description': 'Cmax was defined as the maximum observed plasma concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PAS): all participants who provided at least one evaluable pharmacokinetic (PK) concentration. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'AUClast of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '636', 'spread': '40.8', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '945', 'spread': '56.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose', 'description': 'AUClast was defined as the area under the concentration-time curve up to the last measurable concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.', 'unitOfMeasure': 'ng*hour/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'AUCinf of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '642', 'spread': '32.7', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose', 'description': 'AUCinf was defined as the area under the concentration-time curve from time 0 to infinity. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.', 'unitOfMeasure': 'ng*hour/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'CL/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '32.7', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '20.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose', 'description': 'CL/F was defined as the oral dose clearance of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.', 'unitOfMeasure': 'Liters/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Vz/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.0', 'spread': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.9', 'spread': '33.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose', 'description': 'Vz/F was defined as the apparent oral dose volume of distribution of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Tmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.833', 'groupId': 'OG000', 'lowerLimit': '0.417', 'upperLimit': '4.08'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.417', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose', 'description': 'tmax was defined as the time to reach the maximum plasma concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 't1/2 of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.40', 'spread': '28.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.32', 'spread': '19.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose', 'description': 't1/2 was defined as the apparent terminal phase disposition half-life of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PAS. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Utilization of Medical Resources', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}], 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000'}, {'value': '65.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from Baseline to LPLV (approximately 5 years)', 'description': 'The percentage of participants with at least one submission to healthcare encounter was assessed.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set. Six participants in the BAT arm discontinued before receiving the first dose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'FG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}, {'id': 'FG002', 'title': 'Ruxolitinib Cross-Over Period', 'description': 'Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.'}], 'periods': [{'title': 'End of Randomization Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '164'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '140'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant/Guardian Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Failure to Meet Protocol Continuation Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Disease Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'End of Cross Over Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Participant/Guardian Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Disease Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The study was conducted in 29 countries globally. During the main treatment period, participants were randomly assigned to a ruxolitinib arm or a Best Available Therapy (BAT) arm for 6 cycles of treatment. At the end of Cycle 6, participants in the BAT arm either crossed over to ruxolitinib treatment or entered the survival follow-up phase.', 'preAssignmentDetails': 'A total of 404 participants were screened, of whom 72 were screen failures and 3 were not randomized for various reasons. Out of the 329 participants randomized, 6 did not receive BAT due to logistical reasons. A total of 329 participants were included in the Full Analysis Set (FAS); 165 were in the ruxolitinib arm and 164 were in the BAT arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ruxolitinib', 'description': 'Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).'}, {'id': 'BG001', 'title': 'Best Available Therapy', 'description': "Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '15.68', 'groupId': 'BG000'}, {'value': '47.2', 'spread': '16.17', 'groupId': 'BG001'}, {'value': '46.5', 'spread': '15.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic/Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic/Latino', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}, {'title': 'Not Reported', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG Performance Status', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Eastern Cooperative Oncology Group (ECOG) Performance Score has 6 grades (0-5). 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair. 5 = Death.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-07', 'size': 10307172, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-10T11:38', 'hasProtocol': True}, {'date': '2020-07-06', 'size': 1254035, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-10T11:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03147742', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-08', 'dispFirstSubmitDate': '2021-05-04', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2017-04-04', 'dispFirstSubmitQcDate': '2022-03-22', 'resultsFirstSubmitDate': '2021-12-10', 'studyFirstSubmitQcDate': '2017-04-07', 'dispFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-22', 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit", 'timeFrame': 'Cycle 7 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'ORR was defined as the percentage of participants in each arm demonstrating a complete response (CR) or partial response (PR) based on chronic GvHD (cGvHD) disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies.'}], 'secondaryOutcomes': [{'measure': 'Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score', 'timeFrame': 'Baseline; Cycle 7 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'To assess improvement of symptoms based on the total symptom score (TSS); a responder was defined as having achieved a clinically relevant reduction from Baseline of the TSS. The scale consists of 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). Participants reported their level of symptom "bother" over the previous month on a 5-point likert scale: not at all, slightly, moderately, quite a bit, or extremely. Subscale scores and the summary score range from 0 to 100, with a higher score indicating worse symptoms.'}, {'measure': 'Rate of Failure-free Survival (FFS)', 'timeFrame': 'Baseline to when the last participant reached Cycle 7 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD.'}, {'measure': 'Rate of FFS at Study Completion', 'timeFrame': 'From Baseline to Last Participant Last Visit (LPLV) (approximately 5 years)', 'description': 'Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD.'}, {'measure': 'Best Overall Response (BOR) at Cycle 7 Day 1', 'timeFrame': 'up to Cycle 7 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD). Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. This analysis was based on the primary cutoff date (May 2020).'}, {'measure': 'BOR During Cross-over Treatment With Ruxolitinib', 'timeFrame': 'from Crossover Cycle 1 Day 1 to any time point up to and including Crossover Cycle 7 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD). Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies.'}, {'measure': 'ORR at the End of Cycle 3', 'timeFrame': 'Cycle 4 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'ORR was defined as the percentage of participants in each arm demonstrating a CR or PR based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies.'}, {'measure': 'Duration of Response Through Study Completion', 'timeFrame': 'from first response to LPLV (approximately 5 years)', 'description': 'DOR was defined as the time from first response until cGvHD progression, death, or the date of change/addition of systemic therapies for cGvHD and as assessed for responders only. Response was based on cGvHD disease assessments (National Institutes of Health consensus criteria). Duration of response was evaluated in participants who achieved a CR or PR at or before Cycle 7 Day 1. The analysis included a larger number of participants than the number of participants who achieved CR or PR at Cycle 7 Day 1 (82 ruxolitinib and 42 BAT) because the analysis took into account not only those participants who achieved CR or PR at Cycle 7 Day 1, but also participants who achieved CR or PR before Cycle 7 Day 1 but who may have lost their response at Cycle 7 Day 1. For this reason, the number of participants in this analysis does not align with the best overall response (BOR) at Cycle 7 Day 1. This analysis was based on the cutoff date upon study completion (December 2022).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'from the date of randomization to the date of death due to any cause up to LPLV (approximately 5 years)', 'description': 'Overall survival was defined as the time from the date of randomization to the date of death due to any cause.'}, {'measure': 'Cumulative Incidence of Non-relapse Mortality (NRM)', 'timeFrame': 'Months 3, 6, 12, 18, 24, 30, and 36', 'description': 'Defined as the cumulative incidence rate from competing risk analysis for NRM from the date of randomization to the date of death not preceded by underlying disease relapse/recurrence.'}, {'measure': 'Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose', 'timeFrame': 'from Day 15 up to Day 182', 'description': 'All corticosteroid dosages prescribed to the participant and all dose changes during the study were to be recorded for assessment of participants with a ≥ 50% reduction in daily corticosteroid dose.'}, {'measure': 'Percentage of Participants Successfully Tapered Off of All Corticosteroids', 'timeFrame': 'up to Day 179', 'description': 'All corticosteroid dosages prescribed to the participant and all dose changes during the study were to be recorded for assessment of participants who successfully tapered off of all corticosteroids. Participants who completely tapered off corticosteroids refer to those who permanently discontinued steroids as per the dose administration panel and who did not restart steroids in the same interval. Participants who were tapered off and continued follow-up were also counted as being tapered off with 0 dose in subsequent intervals until they discontinued from the main treatment period or restarted steroid treatment.'}, {'measure': 'Cumulative Incidence of Malignancy Relapse/Recurrence (MR)', 'timeFrame': 'Months 3, 6, 12, 18, 24, 30, and 36', 'description': 'Defined as the cumulative incidence rate from competing risk analysis of MR from the date of randomization to hematologic malignancy relapse/recurrence.'}, {'measure': 'Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)', 'timeFrame': 'Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The FACT-BMT is a 50-item self-report questionnaire that measures the effect of a therapy on domains including physical, functional, social/family, and emotional well-being, together with additional concerns relevant for bone marrow transplantation participants. The questions were based on a 5-point Likert scale, where 0 corresponds to "not at all" and 4 corresponds to "very much." The higher the final score, the better the quality of life. The FACT-BMT total score ranges from 0 to 148.'}, {'measure': 'Change From Baseline in EQ-5D-5L', 'timeFrame': 'Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks)', 'description': 'The EQ-5D-5L is a descriptive classification consisting of five dimensions of health: mobility, self-care, usual activities, anxiety/depression, and pain/discomfort. The five-level version (no problems, slight problems, moderate problems, severe problems, and extreme problems) uses a 5-point Likert scale, with 1 being no problems and 5 being extreme problems.'}, {'measure': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'from Baseline to LPLV (approximately 5 years)', 'description': "Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occurred after the participant's signed informed consent was obtained. Abnormal laboratory values or test results occurring after informed consent constituted adverse events only if they induced clinical signs or symptoms, were considered clinically significant, required therapy (e.g., hematologic abnormality that required transfusion or hematological stem cell support), or required changes in study medication(s). TEAEs were defined as those AEs that started or worsened during the on-treatment period (either randomized or cross-over period)."}, {'measure': 'Cmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses', 'timeFrame': 'Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose', 'description': 'Cmax was defined as the maximum observed plasma concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.'}, {'measure': 'AUClast of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses', 'timeFrame': 'Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose', 'description': 'AUClast was defined as the area under the concentration-time curve up to the last measurable concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.'}, {'measure': 'AUCinf of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses', 'timeFrame': 'Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose', 'description': 'AUCinf was defined as the area under the concentration-time curve from time 0 to infinity. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.'}, {'measure': 'CL/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses', 'timeFrame': 'Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose', 'description': 'CL/F was defined as the oral dose clearance of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.'}, {'measure': 'Vz/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses', 'timeFrame': 'Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose', 'description': 'Vz/F was defined as the apparent oral dose volume of distribution of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.'}, {'measure': 'Tmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses', 'timeFrame': 'Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose', 'description': 'tmax was defined as the time to reach the maximum plasma concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.'}, {'measure': 't1/2 of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses', 'timeFrame': 'Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose', 'description': 't1/2 was defined as the apparent terminal phase disposition half-life of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.'}, {'measure': 'Utilization of Medical Resources', 'timeFrame': 'from Baseline to LPLV (approximately 5 years)', 'description': 'The percentage of participants with at least one submission to healthcare encounter was assessed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Graft-versus-host disease (GvHD)', 'Chronic GvHD (cGvHD)', 'steroid-refractory', 'ruxolitinib', 'Janus kinase inhibitor'], 'conditions': ['Graft-versus-host Disease (GVHD)']}, 'referencesModule': {'references': [{'pmid': '40561385', 'type': 'DERIVED', 'citation': 'Zeiser R, Russo D, Ram R, Hashmi SK, Chakraverty R, Middeke JM, Musso M, Giebel S, Uzay A, Langmuir P, Hamad N, Burock K, Gowda M, Stefanelli T, Lee SJ, Teshima T, Locatelli F. Ruxolitinib in Patients With Corticosteroid-Refractory or Corticosteroid-Dependent Chronic Graft-Versus-Host Disease: 3-Year Final Analysis of the Phase III REACH3 Study. J Clin Oncol. 2025 Aug 10;43(23):2566-2571. doi: 10.1200/JCO-24-02477. Epub 2025 Jun 25.'}, {'pmid': '40472328', 'type': 'DERIVED', 'citation': 'Mahmoudjafari Z, Kintsch E, Xue Z, Bhatt V, Galvin J, Locatelli F, Zeiser R. Impact of concomitant azoles on ruxolitinib treatment in patients with GVHD: post hoc analyses of REACH2 and REACH3. Blood Adv. 2025 Aug 26;9(16):4206-4216. doi: 10.1182/bloodadvances.2025016212.'}, {'pmid': '35363318', 'type': 'DERIVED', 'citation': 'Le RQ, Wang X, Zhang H, Li H, Przepiorka D, Vallejo J, Leong R, Ma L, Goldberg KB, Pazdur R, Theoret MR, De Claro A. FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy. Oncologist. 2022 Jun 8;27(6):493-500. doi: 10.1093/oncolo/oyac042.'}, {'pmid': '34260836', 'type': 'DERIVED', 'citation': 'Zeiser R, Polverelli N, Ram R, Hashmi SK, Chakraverty R, Middeke JM, Musso M, Giebel S, Uzay A, Langmuir P, Hollaender N, Gowda M, Stefanelli T, Lee SJ, Teshima T, Locatelli F; REACH3 Investigators. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. N Engl J Med. 2021 Jul 15;385(3):228-238. doi: 10.1056/NEJMoa2033122.'}, {'pmid': '29316837', 'type': 'DERIVED', 'citation': 'Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have undergone allogeneic stem cell transplantation (alloSCT) from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible\n* Evident myeloid and platelet engraftment: Absolute neutrophil count (ANC) \\> 1000/mm\\^3 and platelet count \\> 25,000/ mm\\^3\n* Participants with clinically diagnosed moderate to severe cGvHD according to NIH Consensus Criteria prior to randomization:\n\n * Moderate cGvHD: At least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1\n * Severe cGvHD: at least 1 organ with a score of 3, or lung score of 2 or 3\n* Participants currently receiving systemic or topical corticosteroids for the treatment of cGvHD for a duration of \\< 12 months prior to Cycle 1 Day 1 (if applicable), and have a confirmed diagnosis of steroid-refractory cGvHD defined per 2014 NIH consensus criteria irrespective of the concomitant use of a calcineurin inhibitor (CNI), as follows:\n\n * A lack of response or disease progression after administration of minimum prednisone 1 mg/kg/day for at least 1 week, OR\n * Disease persistence without improvement despite continued treatment with prednisone at \\> 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks, OR\n * Increase to prednisolone dose to \\> 0.25 mg/kg/day after 2 unsuccessful attempts to taper the dose\n* Participant must accept to be treated with only one of the following BAT options on Cycle 1 Day 1 (additions and changes are allowed during the course of the study, but only with BAT from the following BAT options): extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, ibrutinib\n\nExclusion Criteria:\n\n* Participants who have received 2 or more systemic treatment for cGvHD in addition to corticosteroids ± CNI for cGvHD\n* Patients that transition from active aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment\n\n \\* Patients receiving up to 30 mg by mouth once a day of hydrocortisone (i.e., physiologic replacement dose) of corticosteroids are allowed.\n* Participants who were treated with prior JAK inhibitors for aGvHD; except when the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks prior to Cycle 1 Day 1\n* Failed prior alloSCT within the past 6 months from Cycle 1 Day 1\n* Participants with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed\n* Steroid refractory cGvHD occurring after a non-scheduled donor lymphocyte infusion (DLI) administered for preemptive treatment of malignancy recurrence. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible\n* Any corticosteroid therapy for indications other than cGvHD at doses \\> 1 mg/kg/day methylprednisolone or equivalent within 7 days of Cycle 1 Day 1'}, 'identificationModule': {'nctId': 'NCT03112603', 'briefTitle': 'A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase III Randomized Open-label Multi-center Study of Ruxolitinib vs. Best Available Therapy in Patients With Corticosteroid-refractory Chronic Graft vs Host Disease After Allogeneic Stem Cell Transplantation (REACH3)', 'orgStudyIdInfo': {'id': 'INCB 18424-365 (REACH3)'}, 'secondaryIdInfos': [{'id': 'CINC424D2301', 'type': 'OTHER', 'domain': 'Novartis Pharmaceuticals'}, {'id': '2016-004432-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ruxolitinib', 'description': 'Ruxolitinib for the treatment period and extension period.', 'interventionNames': ['Drug: Ruxolitinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Best Available Therapy', 'description': 'Best available therapy for the treatment period and extension period, with optional crossover to ruxolitinib after Cycle 6.', 'interventionNames': ['Drug: Extracorporeal photopheresis (ECP)', 'Drug: Low-dose methotrexate (MTX)', 'Drug: Mycophenolate mofetil (MMF)', 'Drug: mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus)', 'Drug: Infliximab', 'Drug: Rituximab', 'Drug: Pentostatin', 'Drug: Imatinib', 'Drug: Ibrutinib']}], 'interventions': [{'name': 'Ruxolitinib', 'type': 'DRUG', 'otherNames': ['Jakafi, INCB018424'], 'description': 'Ruxolitinib twice daily at the protocol-defined starting dose.', 'armGroupLabels': ['Ruxolitinib']}, {'name': 'Extracorporeal photopheresis (ECP)', 'type': 'DRUG', 'description': 'Best available therapy (BAT) will be selected by the investigator for each participant. BAT may not include experimental agents (ie, those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements. The BAT in this study will be among the following treatments currently used in this setting (no other types or combinations of BATs are permitted in this study).', 'armGroupLabels': ['Best Available Therapy']}, {'name': 'Low-dose methotrexate (MTX)', 'type': 'DRUG', 'description': "Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.", 'armGroupLabels': ['Best Available Therapy']}, {'name': 'Mycophenolate mofetil (MMF)', 'type': 'DRUG', 'description': "Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.", 'armGroupLabels': ['Best Available Therapy']}, {'name': 'mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus)', 'type': 'DRUG', 'description': "Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.", 'armGroupLabels': ['Best Available Therapy']}, {'name': 'Infliximab', 'type': 'DRUG', 'description': "Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.", 'armGroupLabels': ['Best Available Therapy']}, {'name': 'Rituximab', 'type': 'DRUG', 'description': "Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.", 'armGroupLabels': ['Best Available Therapy']}, {'name': 'Pentostatin', 'type': 'DRUG', 'description': "Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.", 'armGroupLabels': ['Best Available Therapy']}, {'name': 'Imatinib', 'type': 'DRUG', 'description': "Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.", 'armGroupLabels': ['Best Available Therapy']}, {'name': 'Ibrutinib', 'type': 'DRUG', 'description': "Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.", 'armGroupLabels': ['Best Available Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Incyte Investigative Site', 'geoPoint': {'lat': 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