Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-28 @ 12:08 PM
Study NCT ID:
NCT02913261
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2016-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary', 'Poland', 'Portugal', 'Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Directr', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'On treatment deaths were collected from the start of treatment up to 30 days after study drug discontinuation, for a maximum duration of 708 days (treatment duration ranged from 6.0 to 678.0) for the RUX arm and 218 days (treatment duration ranged from 1.0 to 188.0 days) for the BAT arm. Deaths occurred from Randomization till end of the study, up to approx. 48 months.', 'description': 'Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Ruxolitinib (Rux)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 152, 'otherNumAffected': 144, 'seriousNumAtRisk': 152, 'deathsNumAffected': 89, 'seriousNumAffected': 101}, {'id': 'EG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT.", 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 136, 'seriousNumAtRisk': 150, 'deathsNumAffected': 89, 'seriousNumAffected': 80}, {'id': 'EG002', 'title': 'Cross-Over', 'description': 'These were patients randomized to BAT who were eligible to cross over to Ruxolitinib between Day 28 and Week 24.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 43, 'seriousNumAtRisk': 49, 'deathsNumAffected': 29, 'seriousNumAffected': 38}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypogammaglobulinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cytomegalovirus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Epstein-Barr virus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 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'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Mononeuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Posterior reversible encephalopathy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Stupor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cystitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Perineal ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute lung injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bronchial fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Idiopathic pneumonia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lung consolidation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000', 'lowerLimit': '54.2', 'upperLimit': '70.0'}, {'value': '39.4', 'groupId': 'OG001', 'lowerLimit': '31.6', 'upperLimit': '47.5'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.64', 'ciLowerLimit': '1.65', 'ciUpperLimit': '4.22', 'statisticalMethod': 'Stratified Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'Overall response rate at Day 28 after randomization was defined as the percentage participants in each arm demonstrating a complete response (CR) or partial response (PR), based on investigator assessment \\& according to standard criteria, without requirement for additional systemic therapies for an earlier progression, mixed response or non-response. Scoring of response was relative to the organ stage at the time of randomization.\n\nCR was defined as a score of 0 for the aGvHD grading in all evaluable organs that indicates complete resolution of all signs \\& symptoms of aGvHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGvHD.\n\nPR was defined as improvement of 1 stage in 1 or more organs involved with aGvHD signs or symptoms without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response or non-response of aGvHD.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Durable Overall Response Rate (DORR) (Key Secondary Endpoint) at Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000', 'lowerLimit': '31.8', 'upperLimit': '47.8'}, {'value': '21.9', 'groupId': 'OG001', 'lowerLimit': '15.7', 'upperLimit': '29.3'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.38', 'ciLowerLimit': '1.43', 'ciUpperLimit': '3.94', 'statisticalMethod': 'Stratified Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 56', 'description': 'Percentage of all participants in each arm who achieved a complete response (CR) or partial response (PR) at Day 28 (primary endpoint) AND maintained a CR or PR at Day 56 based on investigator assessment and according to standard criteria.\n\nCR was defined as a score of 0 for the aGvHD grading in all evaluable organs that indicates complete resolution of all signs and symptoms of aGvHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGvHD.\n\nPR was defined as improvement of 1 stage in 1 or more organs involved with aGvHD signs or symptoms without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response or non-response of aGvHD.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000', 'lowerLimit': '54.8', 'upperLimit': '70.6'}, {'value': '47.1', 'groupId': 'OG001', 'lowerLimit': '39.0', 'upperLimit': '55.3'}]}]}], 'analyses': [{'pValue': '0.0029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.98', 'ciLowerLimit': '1.24', 'ciUpperLimit': '3.17', 'statisticalMethod': 'Stratified Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'ORR at Da4 14 is the percentage of participants who achieved overall response (CR+PR) at Day 14 based on investigator assessment and according to standard criteria.\n\nCR was defined as a score of 0 for the aGvHD grading in all evaluable organs that indicates complete resolution of all signs and symptoms of aGvHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGvHD.\n\nPR was defined as improvement of 1 stage in 1 or more organs involved with aGvHD signs or symptoms without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response or non-response of aGvHD.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'classes': [{'categories': [{'measurements': [{'value': '167.0', 'groupId': 'OG000', 'lowerLimit': '22.0', 'upperLimit': '677.0'}, {'value': '106.0', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '526.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 months', 'description': 'Duration of response was defined for patients who had a CR or PR at Day 28. This was the interval between the date of first documented response of CR or PR (i.e., the start date of response), till the date of progression or addition of systemic therapies for aGvHD on or after Day 28. Death without prior observation of aGvHD progression and onset of chronic GvHD were considered. Duration of response was censored at the last response assessment prior to or at the analysis cut-off date, if no events/competing risk occurred before or at the cut-off date.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. These were patients to whom study treatment was assigned by randomization and whose overall response was complete response (CR) or partial response (PR).'}, {'type': 'SECONDARY', 'title': 'Cumulative Steroid Dosing Until Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'classes': [{'title': 'By Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '962.5', 'groupId': 'OG000', 'lowerLimit': '140.0', 'upperLimit': '2337.5'}, {'value': '923.6', 'groupId': 'OG001', 'lowerLimit': '140.0', 'upperLimit': '6093.8'}]}]}, {'title': 'By Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1740.0', 'groupId': 'OG000', 'lowerLimit': '280.0', 'upperLimit': '3500.0'}, {'value': '1725.0', 'groupId': 'OG001', 'lowerLimit': '280.0', 'upperLimit': '7173.3'}]}]}, {'title': 'By Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2375.0', 'groupId': 'OG000', 'lowerLimit': '350.0', 'upperLimit': '5250.0'}, {'value': '2340.0', 'groupId': 'OG001', 'lowerLimit': '370.0', 'upperLimit': '8000.0'}]}]}, {'title': 'By Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2866.9', 'groupId': 'OG000', 'lowerLimit': '420.0', 'upperLimit': '7000.0'}, {'value': '2816.3', 'groupId': 'OG001', 'lowerLimit': '420.0', 'upperLimit': '9050.0'}]}]}, {'title': 'By Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3268.1', 'groupId': 'OG000', 'lowerLimit': '455.0', 'upperLimit': '8750.0'}, {'value': '3290.6', 'groupId': 'OG001', 'lowerLimit': '420.0', 'upperLimit': '9825.0'}]}]}, {'title': 'By Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3606.3', 'groupId': 'OG000', 'lowerLimit': '490.0', 'upperLimit': '10500.0'}, {'value': '3543.8', 'groupId': 'OG001', 'lowerLimit': '420.0', 'upperLimit': '10435.0'}]}]}, {'title': 'By Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3850.0', 'groupId': 'OG000', 'lowerLimit': '495.0', 'upperLimit': '11250.0'}, {'value': '3706.3', 'groupId': 'OG001', 'lowerLimit': '420.0', 'upperLimit': '10955.0'}]}]}, {'title': 'By Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4000.0', 'groupId': 'OG000', 'lowerLimit': '857.5', 'upperLimit': '9475.0'}, {'value': '4006.3', 'groupId': 'OG001', 'lowerLimit': '420.0', 'upperLimit': '11875.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to Day 56', 'description': 'Weekly cumulative steroid dose for each participant up to Day 56 or discontinuation of randomized treatment. Participants should have undergone tapering of steroids if it had been required. Tapering the immunosuppression therapy was performed in 2 steps: Taper of corticosteroids: initiated not earlier than Day 7, and performed as per institutional guidelines. Only patients with assessments done at each time point are reported. This is the reason that the overall number per treatment is higher and the number of participants with responses vary over time.', 'unitOfMeasure': 'mg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Kaplan Meier Estimates of Probability of Overall Survival (OS) by Time Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'classes': [{'title': '1 Month', 'categories': [{'measurements': [{'value': '90.04', 'groupId': 'OG000', 'lowerLimit': '84.02', 'upperLimit': '93.87'}, {'value': '85.48', 'groupId': 'OG001', 'lowerLimit': '78.79', 'upperLimit': '90.19'}]}]}, {'title': '2 Months', 'categories': [{'measurements': [{'value': '77.95', 'groupId': 'OG000', 'lowerLimit': '70.42', 'upperLimit': '83.79'}, {'value': '75.69', 'groupId': 'OG001', 'lowerLimit': '67.92', 'upperLimit': '81.83'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '58.38', 'groupId': 'OG000', 'lowerLimit': '50.03', 'upperLimit': '65.82'}, {'value': '49.42', 'groupId': 'OG001', 'lowerLimit': '40.89', 'upperLimit': '57.37'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '49.27', 'groupId': 'OG000', 'lowerLimit': '40.96', 'upperLimit': '57.05'}, {'value': '42.71', 'groupId': 'OG001', 'lowerLimit': '34.39', 'upperLimit': '50.75'}]}]}, {'title': '18 Months', 'categories': [{'measurements': [{'value': '42.94', 'groupId': 'OG000', 'lowerLimit': '34.82', 'upperLimit': '50.79'}, {'value': '37.97', 'groupId': 'OG001', 'lowerLimit': '29.86', 'upperLimit': '46.03'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '38.65', 'groupId': 'OG000', 'lowerLimit': '30.50', 'upperLimit': '46.72'}, {'value': '35.55', 'groupId': 'OG001', 'lowerLimit': '27.57', 'upperLimit': '43.59'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 2, 6, 12, 18 & 24 months', 'description': 'OS was defined as the time from the date of randomization to date of death due to any cause. If a patient was not known to have died, then OS was censored at the latest date the patient was known to be alive (on or before the cut-off date). Results are based on Kaplan Meier (KM) estimates.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Kaplan Meier Estimates of Probability of Event-free Survival (EFS) by Time Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'classes': [{'title': '1 Month', 'categories': [{'measurements': [{'value': '89.38', 'groupId': 'OG000', 'lowerLimit': '83.24', 'upperLimit': '93.35'}, {'value': '82.83', 'groupId': 'OG001', 'lowerLimit': '75.81', 'upperLimit': '87.97'}]}]}, {'title': '2 Months', 'categories': [{'measurements': [{'value': '74.60', 'groupId': 'OG000', 'lowerLimit': '66.82', 'upperLimit': '80.82'}, {'value': '71.72', 'groupId': 'OG001', 'lowerLimit': '63.71', 'upperLimit': '78.26'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '53.68', 'groupId': 'OG000', 'lowerLimit': '45.34', 'upperLimit': '61.30'}, {'value': '44.14', 'groupId': 'OG001', 'lowerLimit': '35.82', 'upperLimit': '52.13'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '44.53', 'groupId': 'OG000', 'lowerLimit': '36.36', 'upperLimit': '52.36'}, {'value': '39.98', 'groupId': 'OG001', 'lowerLimit': '30.90', 'upperLimit': '46.96'}]}]}, {'title': '18 Months', 'categories': [{'measurements': [{'value': '40.29', 'groupId': 'OG000', 'lowerLimit': '32.30', 'upperLimit': '48.12'}, {'value': '35.09', 'groupId': 'OG001', 'lowerLimit': '27.23', 'upperLimit': '43.04'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '34.98', 'groupId': 'OG000', 'lowerLimit': '27.01', 'upperLimit': '43.04'}, {'value': '32.38', 'groupId': 'OG001', 'lowerLimit': '24.61', 'upperLimit': '40.37'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 2, 6, 12, 18 & 24 months', 'description': 'Event-free survival was defined as the time from the date of randomization to the date of hematologic disease relapse/progression, graft failure, or death due to any cause. If a patient was not known to have any event, then EFS was censored at the latest date the patient was known to be alive (on or before the cut-off date). Results are based on Kaplan Meier (KM) estimates.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence Rate of Failure-Free Survival (FFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'classes': [{'title': '1 Month', 'categories': [{'measurements': [{'value': '17.92', 'groupId': 'OG000', 'lowerLimit': '12.26', 'upperLimit': '24.46'}, {'value': '49.13', 'groupId': 'OG001', 'lowerLimit': '40.94', 'upperLimit': '56.80'}]}]}, {'title': '2 Months', 'categories': [{'measurements': [{'value': '35.39', 'groupId': 'OG000', 'lowerLimit': '27.79', 'upperLimit': '43.07'}, {'value': '61.32', 'groupId': 'OG001', 'lowerLimit': '53.00', 'upperLimit': '68.61'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '53.67', 'groupId': 'OG000', 'lowerLimit': '45.28', 'upperLimit': '61.34'}, {'value': '80.17', 'groupId': 'OG001', 'lowerLimit': '72.52', 'upperLimit': '85.89'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '58.64', 'groupId': 'OG000', 'lowerLimit': '50.18', 'upperLimit': '66.16'}, {'value': '80.91', 'groupId': 'OG001', 'lowerLimit': '73.32', 'upperLimit': '86.54'}]}]}, {'title': '18 Months', 'categories': [{'measurements': [{'value': '59.35', 'groupId': 'OG000', 'lowerLimit': '50.88', 'upperLimit': '66.84'}, {'value': '80.91', 'groupId': 'OG001', 'lowerLimit': '73.32', 'upperLimit': '86.54'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '61.48', 'groupId': 'OG000', 'lowerLimit': '53.01', 'upperLimit': '68.88'}, {'value': '81.66', 'groupId': 'OG001', 'lowerLimit': '74.12', 'upperLimit': '87.19'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 2, 6, 12, 18, & 24 Months', 'description': 'FFS was defined as the time from the date of randomization to date of hematologic disease relapse/progression, non-relapse mortality, or addition of new systemic aGvHD treatment.\n\nProbability of FFS with 95% CIs are presented for each treatment group, accounting for onset of chronic GvHD as the competing risk.', 'unitOfMeasure': 'Cumulative probability of FFS', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Cumulative Probability of Non Relapse Mortality (NRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'classes': [{'title': '1 Month', 'categories': [{'measurements': [{'value': '9.96', 'groupId': 'OG000', 'lowerLimit': '5.83', 'upperLimit': '15.39'}, {'value': '14.52', 'groupId': 'OG001', 'lowerLimit': '9.45', 'upperLimit': '20.64'}]}]}, {'title': '2 Months', 'categories': [{'measurements': [{'value': '20.71', 'groupId': 'OG000', 'lowerLimit': '14.61', 'upperLimit': '27.54'}, {'value': '23.54', 'groupId': 'OG001', 'lowerLimit': '17.04', 'upperLimit': '30.65'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '37.59', 'groupId': 'OG000', 'lowerLimit': '29.81', 'upperLimit': '45.33'}, {'value': '42.42', 'groupId': 'OG001', 'lowerLimit': '34.18', 'upperLimit': '50.41'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '43.91', 'groupId': 'OG000', 'lowerLimit': '35.75', 'upperLimit': '51.77'}, {'value': '46.11', 'groupId': 'OG001', 'lowerLimit': '37.68', 'upperLimit': '54.12'}]}]}, {'title': '18 Months', 'categories': [{'measurements': [{'value': '46.03', 'groupId': 'OG000', 'lowerLimit': '37.77', 'upperLimit': '53.89'}, {'value': '49.21', 'groupId': 'OG001', 'lowerLimit': '40.63', 'upperLimit': '57.22'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '49.53', 'groupId': 'OG000', 'lowerLimit': '40.91', 'upperLimit': '57.55'}, {'value': '49.99', 'groupId': 'OG001', 'lowerLimit': '41.38', 'upperLimit': '57.99'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 2, 6, 12, 18 & 24 months', 'description': 'NRM was defined as the time from date of randomization to date of death not preceded by hematologic disease relapse/progression. Hematologic disease relapse/progression was considered a competing risk for NRM with the date of hematologic disease relapse/progression being the earlier of documented hematologic disease relapse/progression or institution of therapy to treat potential hematologic disease relapse/progression. If a patient was not known to have died or to have relapsed/progressed, then NRM was censored at the latest date the patient was known to be alive (on or before the cut-off date). Data is provided based on cumulative probability of hematologic disease relapse/progression.', 'unitOfMeasure': 'Cumulative probability of NRM', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Cumulative Probability of Malignancy Relapse/Progression (MR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'classes': [{'title': '1 Month', 'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '3.51'}, {'value': '2.80', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': '6.54'}]}]}, {'title': '2 Months', 'categories': [{'measurements': [{'value': '4.21', 'groupId': 'OG000', 'lowerLimit': '1.73', 'upperLimit': '8.46'}, {'value': '4.29', 'groupId': 'OG001', 'lowerLimit': '1.75', 'upperLimit': '8.60'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '8.46', 'groupId': 'OG000', 'lowerLimit': '4.60', 'upperLimit': '13.79'}, {'value': '13.49', 'groupId': 'OG001', 'lowerLimit': '8.32', 'upperLimit': '19.91'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '10.68', 'groupId': 'OG000', 'lowerLimit': '6.24', 'upperLimit': '16.47'}, {'value': '15.06', 'groupId': 'OG001', 'lowerLimit': '9.56', 'upperLimit': '21.71'}]}]}, {'title': '18 Months', 'categories': [{'measurements': [{'value': '12.91', 'groupId': 'OG000', 'lowerLimit': '7.96', 'upperLimit': '19.09'}, {'value': '16.72', 'groupId': 'OG001', 'lowerLimit': '10.89', 'upperLimit': '23.64'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '14.75', 'groupId': 'OG000', 'lowerLimit': '9.32', 'upperLimit': '21.37'}, {'value': '18.81', 'groupId': 'OG001', 'lowerLimit': '12.46', 'upperLimit': '26.17'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 2, 6, 12 , 18 & 24 months', 'description': 'MR was defined as the time from date of randomization to hematologic malignancy relapse/progression. Deaths not preceded by hematologic malignancy relapse/progression were considered competing risks. If a patient was not known to have event or competing risks, then MR was censored at the latest date the patient was known to be alive (on or before the cut-off date). Calculated for patients with underlying hematologic malignant disease.', 'unitOfMeasure': 'Cumulative probability of MR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. Calculated for patients with underlying hematologic malignant disease.'}, {'type': 'SECONDARY', 'title': 'Cumulative Probability of Chronic Graft Versus Host Disease (cGvHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'classes': [{'title': '1 Month', 'categories': [{'measurements': [{'value': '0', 'comment': 'N/A: 95% CI could not be achieved as there was no incidence of cGvHD', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.33', 'groupId': 'OG001', 'lowerLimit': '0.26', 'upperLimit': '4.34'}]}]}, {'title': '2 Months', 'categories': [{'measurements': [{'value': '1.34', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '4.39'}, {'value': '2.03', 'groupId': 'OG001', 'lowerLimit': '0.55', 'upperLimit': '5.41'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '15.60', 'groupId': 'OG000', 'lowerLimit': '10.26', 'upperLimit': '21.96'}, {'value': '12.19', 'groupId': 'OG001', 'lowerLimit': '7.40', 'upperLimit': '18.25'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '29.66', 'groupId': 'OG000', 'lowerLimit': '22.41', 'upperLimit': '37.25'}, {'value': '20.24', 'groupId': 'OG001', 'lowerLimit': '13.98', 'upperLimit': '27.34'}]}]}, {'title': '18 Months', 'categories': [{'measurements': [{'value': '32.48', 'groupId': 'OG000', 'lowerLimit': '24.96', 'upperLimit': '40.20'}, {'value': '23.36', 'groupId': 'OG001', 'lowerLimit': '16.62', 'upperLimit': '30.76'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '36.00', 'groupId': 'OG000', 'lowerLimit': '28.20', 'upperLimit': '43.84'}, {'value': '24.95', 'groupId': 'OG001', 'lowerLimit': '18.00', 'upperLimit': '32.50'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 2, 6, 12, 18 & 24 months', 'description': 'Incidence of cGvHD was the time from date of randomization to onset of cGvHD is the diagnosis of any cGvHD including mild, moderate, severe. Deaths without prior onset of cGvHD and hematologic disease relapse/progression were competing risks. If a patient was not known to have event or competing risks, then the incidence of cGvHD was censored at the latest date the patient was known to be alive (on or before the cut-off date).', 'unitOfMeasure': 'Cumulative probability of cGvHD', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. Calculated for patients with underlying hematologic malignant disease.'}, {'type': 'SECONDARY', 'title': 'Exposure-efficacy Relationship of Ruxolitinib in Corticosteroid Refractory aGvHD: PK-Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'Exposure-efficacy relationship of ruxolitinib in terms of concentration-effect and dose-effect.\n\nORR was defined as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR) as assessed by local investigators. CR was defined as a score of 0 for the Acute Graft vs. Host Disease (aGvHD) grading in all evaluable organs that indicates complete resolution of all signs and symptoms of aGvHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGvHD.\n\nPR was defined as improvement of 1 stage in 1 or more organs involved with aGvHD signs or symptoms without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response or non-response of aGvHD.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-Efficacy Set: All patients randomized to ruxolitinib treatment arm, who received at least one dose of ruxolitinib, who have post-baseline efficacy data (at least one efficacy parameter) and for whom popPK predictions are available (at least one popPK predicted AUC0-12h).'}, {'type': 'SECONDARY', 'title': 'Exposure-efficacy Relationship of Ruxolitinib in Corticosteroid Refractory aGvHD: PK- Durable Overall Response Rate (DORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 56', 'description': 'Exposure-efficacy relationship of ruxolitinib in terms of concentration-effect and dose-effect.\n\nDORR is the percentage of all participants in each arm who achieved a complete response (CR) or partial response (PR) at Day 28 (primary endpoint) AND maintained a CR or PR at Day 56.\n\nCR was defined as a score of 0 for the aGvHD grading in all evaluable organs that indicates complete resolution of all signs and symptoms of aGvHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGvHD.\n\nPR was defined as improvement of 1 stage in 1 or more organs involved with aGvHD signs or symptoms without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response or non-response of aGvHD.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-Efficacy Set: PK-Efficacy Set: All patients randomized to ruxolitinib treatment arm, who received at least one dose of ruxolitinib, who have post-baseline efficacy data (at least one efficacy parameter) and for whom popPK predictions are available (at least one popPK predicted AUC0-12h).'}, {'type': 'SECONDARY', 'title': 'Exposure-efficacy Relationship of Ruxolitinib in Corticosteroid Refractory aGvHD: PK-Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 24 months', 'description': 'Exposure-efficacy relationship of ruxolitinib in terms of concentration-effect and dose-effect. This represents the percentage of Ruxolitinib-exposed participants dead at 24 months.\n\nOverall survival (OS) was defined as the time from the date of randomization to date of death due to any cause. If a patient was not known to have died, then OS was censored at the latest date the patient was known to be alive (on or before the cut-off date).the date of death due to any cause.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-Efficacy Set: PK-Efficacy Set: All patients randomized to ruxolitinib treatment arm, who received at least one dose of ruxolitinib, who have post-baseline efficacy data (at least one efficacy parameter) and for whom popPK predictions are available (at least one popPK predicted AUC0-12h).'}, {'type': 'SECONDARY', 'title': 'Best Overall Response Rate (BOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'classes': [{'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000', 'lowerLimit': '74.8', 'upperLimit': '87.6'}, {'value': '60.6', 'groupId': 'OG001', 'lowerLimit': '52.5', 'upperLimit': '68.4'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.07', 'ciLowerLimit': '1.80', 'ciUpperLimit': '5.25', 'statisticalMethod': 'Stratified Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to Day 28', 'description': 'Percentage of participants who achieved overall response (OR) (CR+PR) at any time point up to and including Day 28 and before the start of additional systemic therapy for aGvHD.\n\nCR was defined as a score of 0 for the Acute Graft vs. Host Disease (aGvHD) grading in all evaluable organs that indicates complete resolution of all signs and symptoms of aGvHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGvHD.\n\nPR was defined as improvement of 1 stage in 1 or more organs involved with aGvHD signs or symptoms without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response or non-response of aGvHD.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization. These were participants whose overall response was complete response (CR) or partial response (PR).'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes (PROs): Change From Baseline in Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.00', 'groupId': 'OG000', 'lowerLimit': '41.0', 'upperLimit': '138.0'}, {'value': '81.00', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '129.0'}]}]}, {'title': 'Week (W) 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108.50', 'groupId': 'OG000', 'lowerLimit': '67.0', 'upperLimit': '139.0'}, {'value': '86.00', 'groupId': 'OG001', 'lowerLimit': '21.0', 'upperLimit': '124.0'}]}]}, {'title': 'Change from Baseline to W24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.00', 'groupId': 'OG000', 'lowerLimit': '-40.0', 'upperLimit': '44.0'}, {'value': '4.50', 'groupId': 'OG001', 'lowerLimit': '-29.0', 'upperLimit': '41.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The Functional assessment of Cancer Therapy - Bone Marrow Transplant (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 patients. Patients indicated their response on a scale of 0 to 4 on each statement, with 0 indicating worst score and 4 the best score. All individual scores were combined to calculate the total score. Total score was reported with score range: 0-148 which was calculated as the sum of all unweighted subscale scores. The higher the total score the better the result. Descriptive statistics and change from baseline were calculated in total score at each scheduled assessment time point.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes (PROs): Change From Baseline in EuroQol-5D-5L UK Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '1.0'}, {'value': '0.54', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '1.0'}]}]}, {'title': 'W24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '1.0'}, {'value': '0.68', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '1.0'}]}]}, {'title': 'Change from Baseline to W24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '1.1'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The EQ-5D descriptive classification consists of five dimensions of health: mobility, self-care, usual activities, anxiety/depression and pain/discomfort. Patients are requested to select the statement which best describes their condition on that day for each dimension. For overall health that day, the EuroQoL-5D-5L scale is numbered from 0 to 100, with 100 being the best health you can imagine and 0 being the worst health you can imagine. Descriptive statistics (mean, standard deviation, median, Q1, Q3, minimum, and maximum) were calculated based on the scored scales at each scheduled assessment time point. In order to measure Quality-of-Life (QoL) among aGvHD patients, and potential changes over time, change from baseline in EuroQol-5D-5L scores at the time of each assessment were also calculated. Missing items data in a scale will be handled based on each instrument manual. No imputation will be applied if the total or subscale scores are missing at a visit.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC) (AUCinf, AUClast, AUCtau) of Ruxolitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}], 'classes': [{'title': 'Week 1 Day 1 AUCinf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '529.6', 'spread': '55.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 Day 1 AUClast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '522.9', 'spread': '89.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 Day 1 AUCtau', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '578.9', 'spread': '97.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 Day 7 AUCinf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '440.9', 'spread': '91.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 Day 7 AUClast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '597.3', 'spread': '73.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 Day 7 AUCtau', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '651.9', 'spread': '86.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) AUCinf: The AUC from time zero to infinity (mass x time x volume-1) AUCtau: The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1).\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients was assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set (PAS) included all patients who provided at least one evaluable PK concentration. For a concentration to be evaluable, patients were required to: Take a dose of ruxolitinib prior to sampling, Did not vomit within 2 hours after the last dose of ruxolitinib prior to sampling (for pre dose samples) or did not vomit within 2 hours after ruxolitinib dosing (for post dose samples).'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter: Plasma Concentration at Peak (Cmax) of Ruxolitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}], 'classes': [{'title': 'Week 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '118', 'spread': '70.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '129.3', 'spread': '76.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass X volume-1).\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients was assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set (PAS) included all patients who provided at least one evaluable PK concentration. For a concentration to be evaluable, patients were required to: Take a dose of ruxolitinib prior to sampling, Did not vomit within 2 hours after the last dose of ruxolitinib prior to sampling (for pre dose samples) or did not vomit within 2 hours after ruxolitinib dosing (for post dose samples).'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter: CL/F of Ruxolitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}], 'classes': [{'title': 'Week 1 Day 1 CL/F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.88', 'spread': '55.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 Day 7 CL/F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.31', 'spread': '89.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'CL/F is the total body clearance of ruxolitinib from the plasma after a single dose and at steady state.\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients was assayed for Ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set (PAS) included all patients who provided at least one evaluable PK concentration. For a concentration to be evaluable, patients were required to: Take a dose of ruxolitinib prior to sampling, Did not vomit within 2 hours after the last dose of ruxolitinib prior to sampling (for pre dose samples) or did not vomit within 2 hours after ruxolitinib dosing (for post dose samples).'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter: VzF of Ruxolitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}], 'classes': [{'title': 'Week 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.57', 'spread': '46.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.76', 'spread': '71.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'VzF is the apparent volume of distribution during terminal phase after a single dose and at steady state.\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients will be assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).', 'unitOfMeasure': 'Liters (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set (PAS) included all patients who provided at least one evaluable PK concentration. For a concentration to be evaluable, patients were required to: Take a dose of ruxolitinib prior to sampling, Did not vomit within 2 hours after the last dose of ruxolitinib prior to sampling (for pre dose samples) or did not vomit within 2 hours after ruxolitinib dosing (for post dose samples).'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter: Lambda_z of Ruxolitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}], 'classes': [{'title': 'Week 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3592', 'spread': '34.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3492', 'spread': '31.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'Lambda\\_z is the smallest (slowest) disposition (hybrid) rate constant (hr-1) may also be used for terminal elimination rate constant (hr-1).\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients will be assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).', 'unitOfMeasure': '1/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set (PAS) included all patients who provided at least one evaluable PK concentration. For a concentration to be evaluable, patients were required to: Take a dose of ruxolitinib prior to sampling, Did not vomit within 2 hours after the last dose of ruxolitinib prior to sampling (for pre dose samples) or did not vomit within 2 hours after ruxolitinib dosing (for post dose samples).'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter: T1/2 of Ruxolitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}], 'classes': [{'title': 'Week 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.93', 'spread': '34.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.985', 'spread': '31.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'T1/2 is the elimination half-life associated with the terminal slope of a semi logarithmic concentration-time curve (hr).\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients will be assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).', 'unitOfMeasure': 'hour (hr)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set (PAS) included all patients who provided at least one evaluable PK concentration. For a concentration to be evaluable, patients were required to: Take a dose of ruxolitinib prior to sampling, Did not vomit within 2 hours after the last dose of ruxolitinib prior to sampling (for pre dose samples) or did not vomit within 2 hours after ruxolitinib dosing (for post dose samples).'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter: Tmax of Ruxolitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}], 'classes': [{'title': 'Week 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.767', 'groupId': 'OG000', 'lowerLimit': '0.5167', 'upperLimit': '8.917'}]}]}, {'title': 'Week 1 Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.542', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '4.083'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose and repeated dose administration (hr).\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients will be assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).', 'unitOfMeasure': 'hour (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set (PAS) included all patients who provided at least one evaluable PK concentration. For a concentration to be evaluable, patients were required to: Take a dose of ruxolitinib prior to sampling, Did not vomit within 2 hours after the last dose of ruxolitinib prior to sampling (for pre dose samples) or did not vomit within 2 hours after ruxolitinib dosing (for post dose samples).'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter: Racc of Ruxolitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.145', 'spread': '27.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'Racc is the accumulation ratio (AUC at steady state/AUC Day 1). Plasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients was be assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set (PAS) included all patients who provided at least one evaluable PK concentration. For a concentration to be evaluable, patients were required to: Take a dose of ruxolitinib prior to sampling, Did not vomit within 2 hours after the last dose of ruxolitinib prior to sampling (for pre dose samples) or did not vomit within 2 hours after ruxolitinib dosing (for post dose samples).'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter: Ctrough of Ruxolitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.22', 'spread': '187.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose', 'description': 'Minimum concentration (Ctrough) of ruxolitinib and at steady state in corticosteroid refractory acute GVHD patients.\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients will be assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS)', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set (PAS) included all patients who provided at least one evaluable PK concentration. For a concentration to be evaluable, patients were required to: Take a dose of ruxolitinib prior to sampling, Did not vomit within 2 hours after the last dose of ruxolitinib prior to sampling (for pre dose samples) or did not vomit within 2 hours after ruxolitinib dosing (for post dose samples).'}, {'type': 'POST_HOC', 'title': 'All Collected Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}, {'id': 'OG002', 'title': 'Cross-Over', 'description': 'These were patients randomized to BAT who were eligible to cross over to Ruxolitinib between Day 28 and Week 24.'}], 'classes': [{'title': 'Total Deaths', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Deaths on-treatment', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'approx. 708 days (AEs), up to approx. 48 months (deaths)', 'description': "On treatment deaths were collected from the start of treatment up to 30 days after study drug discontinuation, for a maximum duration of 708 days (treatment duration ranged from 6.0 to 678.0) for the RUX arm and 218 days (treatment duration ranged from 1.0 to 188.0 days) for the BAT arm.\n\nDeaths post treatment survival follow up were collected after the on- treatment period, up to approx. 48 months. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical Database Population: all randomized patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'FG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '155'}]}, {'type': 'Not Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Crossover Treatment at End of Randomized Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'Entered Long-term Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'Completed Screening & Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '155'}]}, {'type': 'Completed Screening & Not Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Completed the treatment period Not Completed = Discontinued from treatment period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '135'}]}], 'dropWithdraws': [{'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Failure to meet protocol continuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Disease relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Subject/guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Graft loss', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 310 patients with SR-aGvHD were enrolled, out of which 309 patients were included in the analysis (as one patient did not sign the study informed consent prior to receiving BAT (protocol deviation) and was excluded from all analyses).\n\nCompleted = Completed the treatment period Not completed = Discontinued from treatment period', 'preAssignmentDetails': 'The screening period ranged from Day -28 to Day -1. Screening activities and assessment of inclusion and exclusion criteria began once the patient was diagnosed with aGvHD. Any occurrence of SR-aGvHD was monitored closely.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ruxolitinib (RUX)', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.'}, {'id': 'BG001', 'title': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48.1', 'spread': '16.30', 'groupId': 'BG000'}, {'value': '50.9', 'spread': '14.97', 'groupId': 'BG001'}, {'value': '49.5', 'spread': '15.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Adolescents, 12 - <18 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': '18 - 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}]}, {'title': '>65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67.5', 'spread': '14.04', 'groupId': 'BG000'}, {'value': '66.2', 'spread': '14.78', 'groupId': 'BG001'}, {'value': '66.9', 'spread': '14.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'the weight at baseline was missing for 7 patients'}], 'populationDescription': 'Full Analysis Set (FAS): The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-21', 'size': 3810001, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-23T14:27', 'hasProtocol': True}, {'date': '2021-05-25', 'size': 4528301, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-23T14:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2016-09-18', 'resultsFirstSubmitDate': '2021-10-23', 'studyFirstSubmitQcDate': '2016-09-21', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-09', 'studyFirstPostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR) at Day 28', 'timeFrame': 'Day 28', 'description': 'Overall response rate at Day 28 after randomization was defined as the percentage participants in each arm demonstrating a complete response (CR) or partial response (PR), based on investigator assessment \\& according to standard criteria, without requirement for additional systemic therapies for an earlier progression, mixed response or non-response. Scoring of response was relative to the organ stage at the time of randomization.\n\nCR was defined as a score of 0 for the aGvHD grading in all evaluable organs that indicates complete resolution of all signs \\& symptoms of aGvHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGvHD.\n\nPR was defined as improvement of 1 stage in 1 or more organs involved with aGvHD signs or symptoms without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response or non-response of aGvHD.'}], 'secondaryOutcomes': [{'measure': 'Durable Overall Response Rate (DORR) (Key Secondary Endpoint) at Day 56', 'timeFrame': 'Day 56', 'description': 'Percentage of all participants in each arm who achieved a complete response (CR) or partial response (PR) at Day 28 (primary endpoint) AND maintained a CR or PR at Day 56 based on investigator assessment and according to standard criteria.\n\nCR was defined as a score of 0 for the aGvHD grading in all evaluable organs that indicates complete resolution of all signs and symptoms of aGvHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGvHD.\n\nPR was defined as improvement of 1 stage in 1 or more organs involved with aGvHD signs or symptoms without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response or non-response of aGvHD.'}, {'measure': 'Overall Response Rate (ORR) at Day 14', 'timeFrame': 'Day 14', 'description': 'ORR at Da4 14 is the percentage of participants who achieved overall response (CR+PR) at Day 14 based on investigator assessment and according to standard criteria.\n\nCR was defined as a score of 0 for the aGvHD grading in all evaluable organs that indicates complete resolution of all signs and symptoms of aGvHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGvHD.\n\nPR was defined as improvement of 1 stage in 1 or more organs involved with aGvHD signs or symptoms without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response or non-response of aGvHD.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 24 months', 'description': 'Duration of response was defined for patients who had a CR or PR at Day 28. This was the interval between the date of first documented response of CR or PR (i.e., the start date of response), till the date of progression or addition of systemic therapies for aGvHD on or after Day 28. Death without prior observation of aGvHD progression and onset of chronic GvHD were considered. Duration of response was censored at the last response assessment prior to or at the analysis cut-off date, if no events/competing risk occurred before or at the cut-off date.'}, {'measure': 'Cumulative Steroid Dosing Until Day 56', 'timeFrame': 'up to Day 56', 'description': 'Weekly cumulative steroid dose for each participant up to Day 56 or discontinuation of randomized treatment. Participants should have undergone tapering of steroids if it had been required. Tapering the immunosuppression therapy was performed in 2 steps: Taper of corticosteroids: initiated not earlier than Day 7, and performed as per institutional guidelines. Only patients with assessments done at each time point are reported. This is the reason that the overall number per treatment is higher and the number of participants with responses vary over time.'}, {'measure': 'Kaplan Meier Estimates of Probability of Overall Survival (OS) by Time Interval', 'timeFrame': '1, 2, 6, 12, 18 & 24 months', 'description': 'OS was defined as the time from the date of randomization to date of death due to any cause. If a patient was not known to have died, then OS was censored at the latest date the patient was known to be alive (on or before the cut-off date). Results are based on Kaplan Meier (KM) estimates.'}, {'measure': 'Kaplan Meier Estimates of Probability of Event-free Survival (EFS) by Time Interval', 'timeFrame': '1, 2, 6, 12, 18 & 24 months', 'description': 'Event-free survival was defined as the time from the date of randomization to the date of hematologic disease relapse/progression, graft failure, or death due to any cause. If a patient was not known to have any event, then EFS was censored at the latest date the patient was known to be alive (on or before the cut-off date). Results are based on Kaplan Meier (KM) estimates.'}, {'measure': 'Cumulative Incidence Rate of Failure-Free Survival (FFS)', 'timeFrame': '1, 2, 6, 12, 18, & 24 Months', 'description': 'FFS was defined as the time from the date of randomization to date of hematologic disease relapse/progression, non-relapse mortality, or addition of new systemic aGvHD treatment.\n\nProbability of FFS with 95% CIs are presented for each treatment group, accounting for onset of chronic GvHD as the competing risk.'}, {'measure': 'Cumulative Probability of Non Relapse Mortality (NRM)', 'timeFrame': '1, 2, 6, 12, 18 & 24 months', 'description': 'NRM was defined as the time from date of randomization to date of death not preceded by hematologic disease relapse/progression. Hematologic disease relapse/progression was considered a competing risk for NRM with the date of hematologic disease relapse/progression being the earlier of documented hematologic disease relapse/progression or institution of therapy to treat potential hematologic disease relapse/progression. If a patient was not known to have died or to have relapsed/progressed, then NRM was censored at the latest date the patient was known to be alive (on or before the cut-off date). Data is provided based on cumulative probability of hematologic disease relapse/progression.'}, {'measure': 'Cumulative Probability of Malignancy Relapse/Progression (MR)', 'timeFrame': '1, 2, 6, 12 , 18 & 24 months', 'description': 'MR was defined as the time from date of randomization to hematologic malignancy relapse/progression. Deaths not preceded by hematologic malignancy relapse/progression were considered competing risks. If a patient was not known to have event or competing risks, then MR was censored at the latest date the patient was known to be alive (on or before the cut-off date). Calculated for patients with underlying hematologic malignant disease.'}, {'measure': 'Cumulative Probability of Chronic Graft Versus Host Disease (cGvHD)', 'timeFrame': '1, 2, 6, 12, 18 & 24 months', 'description': 'Incidence of cGvHD was the time from date of randomization to onset of cGvHD is the diagnosis of any cGvHD including mild, moderate, severe. Deaths without prior onset of cGvHD and hematologic disease relapse/progression were competing risks. If a patient was not known to have event or competing risks, then the incidence of cGvHD was censored at the latest date the patient was known to be alive (on or before the cut-off date).'}, {'measure': 'Exposure-efficacy Relationship of Ruxolitinib in Corticosteroid Refractory aGvHD: PK-Overall Response Rate', 'timeFrame': 'Day 28', 'description': 'Exposure-efficacy relationship of ruxolitinib in terms of concentration-effect and dose-effect.\n\nORR was defined as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR) as assessed by local investigators. CR was defined as a score of 0 for the Acute Graft vs. Host Disease (aGvHD) grading in all evaluable organs that indicates complete resolution of all signs and symptoms of aGvHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGvHD.\n\nPR was defined as improvement of 1 stage in 1 or more organs involved with aGvHD signs or symptoms without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response or non-response of aGvHD.'}, {'measure': 'Exposure-efficacy Relationship of Ruxolitinib in Corticosteroid Refractory aGvHD: PK- Durable Overall Response Rate (DORR)', 'timeFrame': 'Day 56', 'description': 'Exposure-efficacy relationship of ruxolitinib in terms of concentration-effect and dose-effect.\n\nDORR is the percentage of all participants in each arm who achieved a complete response (CR) or partial response (PR) at Day 28 (primary endpoint) AND maintained a CR or PR at Day 56.\n\nCR was defined as a score of 0 for the aGvHD grading in all evaluable organs that indicates complete resolution of all signs and symptoms of aGvHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGvHD.\n\nPR was defined as improvement of 1 stage in 1 or more organs involved with aGvHD signs or symptoms without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response or non-response of aGvHD.'}, {'measure': 'Exposure-efficacy Relationship of Ruxolitinib in Corticosteroid Refractory aGvHD: PK-Overall Survival', 'timeFrame': 'up to 24 months', 'description': 'Exposure-efficacy relationship of ruxolitinib in terms of concentration-effect and dose-effect. This represents the percentage of Ruxolitinib-exposed participants dead at 24 months.\n\nOverall survival (OS) was defined as the time from the date of randomization to date of death due to any cause. If a patient was not known to have died, then OS was censored at the latest date the patient was known to be alive (on or before the cut-off date).the date of death due to any cause.'}, {'measure': 'Best Overall Response Rate (BOR)', 'timeFrame': 'up to Day 28', 'description': 'Percentage of participants who achieved overall response (OR) (CR+PR) at any time point up to and including Day 28 and before the start of additional systemic therapy for aGvHD.\n\nCR was defined as a score of 0 for the Acute Graft vs. Host Disease (aGvHD) grading in all evaluable organs that indicates complete resolution of all signs and symptoms of aGvHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGvHD.\n\nPR was defined as improvement of 1 stage in 1 or more organs involved with aGvHD signs or symptoms without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response or non-response of aGvHD.'}, {'measure': 'Patient Reported Outcomes (PROs): Change From Baseline in Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) Total Score', 'timeFrame': 'Baseline, Week 24', 'description': 'The Functional assessment of Cancer Therapy - Bone Marrow Transplant (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 patients. Patients indicated their response on a scale of 0 to 4 on each statement, with 0 indicating worst score and 4 the best score. All individual scores were combined to calculate the total score. Total score was reported with score range: 0-148 which was calculated as the sum of all unweighted subscale scores. The higher the total score the better the result. Descriptive statistics and change from baseline were calculated in total score at each scheduled assessment time point.'}, {'measure': 'Patient Reported Outcomes (PROs): Change From Baseline in EuroQol-5D-5L UK Score', 'timeFrame': 'Baseline, Week 24', 'description': 'The EQ-5D descriptive classification consists of five dimensions of health: mobility, self-care, usual activities, anxiety/depression and pain/discomfort. Patients are requested to select the statement which best describes their condition on that day for each dimension. For overall health that day, the EuroQoL-5D-5L scale is numbered from 0 to 100, with 100 being the best health you can imagine and 0 being the worst health you can imagine. Descriptive statistics (mean, standard deviation, median, Q1, Q3, minimum, and maximum) were calculated based on the scored scales at each scheduled assessment time point. In order to measure Quality-of-Life (QoL) among aGvHD patients, and potential changes over time, change from baseline in EuroQol-5D-5L scores at the time of each assessment were also calculated. Missing items data in a scale will be handled based on each instrument manual. No imputation will be applied if the total or subscale scores are missing at a visit.'}, {'measure': 'Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC) (AUCinf, AUClast, AUCtau) of Ruxolitinib', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) AUCinf: The AUC from time zero to infinity (mass x time x volume-1) AUCtau: The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1).\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients was assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).'}, {'measure': 'Pharmacokinetic (PK) Parameter: Plasma Concentration at Peak (Cmax) of Ruxolitinib', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass X volume-1).\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients was assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).'}, {'measure': 'Pharmacokinetic (PK) Parameter: CL/F of Ruxolitinib', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'CL/F is the total body clearance of ruxolitinib from the plasma after a single dose and at steady state.\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients was assayed for Ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).'}, {'measure': 'Pharmacokinetic (PK) Parameter: VzF of Ruxolitinib', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'VzF is the apparent volume of distribution during terminal phase after a single dose and at steady state.\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients will be assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).'}, {'measure': 'Pharmacokinetic (PK) Parameter: Lambda_z of Ruxolitinib', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'Lambda\\_z is the smallest (slowest) disposition (hybrid) rate constant (hr-1) may also be used for terminal elimination rate constant (hr-1).\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients will be assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).'}, {'measure': 'Pharmacokinetic (PK) Parameter: T1/2 of Ruxolitinib', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'T1/2 is the elimination half-life associated with the terminal slope of a semi logarithmic concentration-time curve (hr).\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients will be assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).'}, {'measure': 'Pharmacokinetic (PK) Parameter: Tmax of Ruxolitinib', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose and repeated dose administration (hr).\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients will be assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).'}, {'measure': 'Pharmacokinetic (PK) Parameter: Racc of Ruxolitinib', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 4, 6, 9 hrs post-dose', 'description': 'Racc is the accumulation ratio (AUC at steady state/AUC Day 1). Plasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients was be assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS).'}, {'measure': 'Pharmacokinetic (PK) Parameter: Ctrough of Ruxolitinib', 'timeFrame': 'pre-dose', 'description': 'Minimum concentration (Ctrough) of ruxolitinib and at steady state in corticosteroid refractory acute GVHD patients.\n\nPlasma samples for PK was taken at Day 1 (start of treatment), at Day 7 (week 1) to characterize the PK after first dose, and at steady state by non-compartmental analysis.\n\nThe plasma samples from all patients will be assayed for ruxolitinib concentrations using validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GvHD (Graft versus Host Disease)', 'INC424', 'ruxolitinib', 'best available therapy (BAT)', 'corticosteroid-refractory acute graft vs. host disease', 'allogeneic stem cell transplantation', 'steroid refractory acute graft vs. host disease', 'Janus Kinase (JAK) inhibitor'], 'conditions': ['Corticosteroid Refractory Acute Graft vs Host Disease']}, 'referencesModule': {'references': [{'pmid': '41092247', 'type': 'DERIVED', 'citation': 'Mohty M, Socie G, Szer J, Niederwieser D, Butler J, Wagner-Drouet E, Or R, Rovenvald-Zuckerman T, Bozdag SC, Forcade E, Grillo G, Kroger N, Stolzel F, Russo D, Sanz J, Sarkar R, Stefanelli T, Wilke C, Zeiser R, von Bubnoff N. Ruxolitinib Versus Best Available Therapy in Patients With Steroid-Refractory Acute Graft-Versus-Host Disease: Final Analysis From the Randomized Phase III REACH2 Trial. J Clin Oncol. 2025 Dec;43(34):3639-3645. doi: 10.1200/JCO-25-00809. Epub 2025 Oct 15.'}, {'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': '36827620', 'type': 'DERIVED', 'citation': 'Socie G, Niederwieser D, von Bubnoff N, Mohty M, Szer J, Or R, Garrett J, Prahallad A, Wilke C, Zeiser R. Prognostic value of blood biomarkers in steroid-refractory or steroid-dependent acute graft-versus-host disease: a REACH2 analysis. Blood. 2023 Jun 1;141(22):2771-2779. doi: 10.1182/blood.2022018579.'}, {'pmid': '32320566', 'type': 'DERIVED', 'citation': 'Zeiser R, von Bubnoff N, Butler J, Mohty M, Niederwieser D, Or R, Szer J, Wagner EM, Zuckerman T, Mahuzier B, Xu J, Wilke C, Gandhi KK, Socie G; REACH2 Trial Group. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease. N Engl J Med. 2020 May 7;382(19):1800-1810. doi: 10.1056/NEJMoa1917635. Epub 2020 Apr 22.'}, {'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': 'Assess the efficacy and safety of ruxolitinib compared to Best Available Therapy (BAT) in patients with corticosteroid-refractory acute graft vs. host disease (aGvHD) after allogeneic stem cell transplantation.', 'detailedDescription': "This randomized, phase III, open-label study investigated the efficacy and safety of ruxolitinib vs. BAT added to the patient's immunosuppressive regimen in adults and adolescents (≥ 12 years old) with grade II-IV Steroid-refractory Acute Graft vs. Host Disease (SR-aGvHD). During the screening period, patients were monitored for a diagnosis of SR-aGvHD, which was defined as patients who had high-dose systemic corticosteroids (methylprednisolone 2 mg/kg/day \\[or equivalent prednisone dose 2.5 mg/kg/day\\]), given alone or combined with CNI, who either:\n\n1. Progressed based on organ assessment after at least 3 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD, OR\n2. Failed to achieve at a minimum a partial response based on organ assessment after 7 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD, OR\n3. Failed corticosteroid taper defined as fulfilling either one of the following criteria:\n\n * Requirement for an increase in the corticosteroid dose to methylprednisolone ≥ 2 mg/kg/day (or equivalent prednisone dose ≥ 2.5 mg/kg/day) OR\n * Failure to taper the methylprednisolone dose to \\<0.5 mg/kg/day (or equivalent prednisone dose \\<0.6 mg/kg/day) for a minimum 7 days.\n\nPatients meeting eligibility criteria were randomized 1:1 to receive either ruxolitinib or BAT stratifying on aGvHD grade at the time of randomization (Grade II vs III vs IV).\n\nStudy treatment began on Day 1 (no later than 72 hours after randomization) followed by regular visits for assessments of efficacy and safety. Study treatment was administered until the patient met any of the criteria for discontinuation of study treatment or, in responders (i.e. patients achieving PR or CR) until the dosing schedule for ruxolitinib or BAT was completed.\n\nAll responders were to be tapered off during the treatment period by, first tapering from corticosteroids, followed by CNI and ruxolitinib. A slow tapering extending beyond 24 weeks was permitted for ruxolitinib at Investigator's discretion rather than an abrupt cessation, as the latter could result in an aGvHD flare.\n\nDuring the Treatment Period, patients randomized to BAT could have crossed over to ruxolitinib between Day 28 and Week 24 if they:\n\n* Failed to meet the primary endpoint response definition (CR or PR) at Day 28 OR\n* Lost the response thereafter and met criteria for progression, mixed response, or no response, necessitating new additional systemic immunosuppressive treatment for aGvHD.\n\nAND\n\n\\- Did not have signs/symptoms of chronic Graft vs. Host Disease (cGvHD) (overlap syndrome, progressive, or de novo cGvHD)\n\nPatients who crossed over to ruxolitinib were followed until completion of treatment with ruxolitinib and received the same treatment and tapering schedule as patients randomized to ruxolitinib treatment.\n\nThe End of Treatment (EOT) visit occurred when the patient completed the study treatment period or earlier if the patient met any of the criteria for discontinuation of study treatment.\n\nPatient's treatment period was up to 6 months (Week 24). However, ruxolitinib taper could be delayed up to 2 years from randomization due to an aGvHD flare or other safety concerns."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have undergone Allogeneic Stem Cell Transplanttaion (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* Clinically diagnosed Grades II to IV acute GvHD as per standard criteria occurring after alloSCT requiring systemic immune suppressive therapy. Biopsy of involved organs with aGvHD is encouraged but not required for study screening.\n* Confirmed diagnosis of steroid refractory aGvHD defined as patients administered high-dose systemic corticosteroids (methylprednisolone 2 mg/kg/day \\[or equivalent prednisone dose 2.5 mg/kg/day\\]), given alone or combined with calcineurin inhibitors (CNI) and either:\n\n * Progressing based on organ assessment after at least 3 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD, OR\n * Failure to achieve at a minimum partial response based on organ assessment after 7 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD,OR\n * Patients who fail corticosteroid taper defined as fulfilling either one of the following criteria:\n* Requirement for an increase in the corticosteroid dose to methylprednisolone ≥2 mg/kg/day (or equivalent prednisone dose ≥2.5 mg/kg/day) , OR\n* Failure to taper the methylprednisolone dose to \\<0.5 mg/kg/day (or equivalent prednisone dose \\<0.6 mg/kg/day) for a minimum 7 days.\n\nExclusion Criteria:\n\n* Has received more than one systemic treatment for steroid refractory aGvHD.\n* Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n* Evidence of uncontrolled viral infection including Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Human Herpes Virus-6 (HHV-6), Hepatitis Virus (HBV), or Hepatitis C Virus (HCV) based on assessment by the treating physician.\n* Presence of relapsed primary malignancy, or who have been treated for relapse after the alloHSCT was performed, or who may require rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse.'}, 'identificationModule': {'nctId': 'NCT02913261', 'acronym': 'REACH2', 'briefTitle': 'Safety and Efficacy of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III Randomized Open-label Multi-center Study of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'CINC424C2301'}, 'secondaryIdInfos': [{'id': '2016-002584-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ruxolitinib', 'description': 'These patients were administered Ruxolitinib orally twice per day (b.i.d) at a dose of 10 mg bid, as two 5-mg tablets. Ruxolitinib was taken without regards to food.', 'interventionNames': ['Drug: Ruxolitinib (RUX)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Best Available Therapy (BAT)', 'description': "These patients were administered BAT per the Investigator's best judgement based on a specific list of BAT.", 'interventionNames': ['Drug: Best Available Therapy (BAT)']}], 'interventions': [{'name': 'Ruxolitinib (RUX)', 'type': 'DRUG', 'otherNames': ['INC424'], 'description': 'Ruxolitinib was provided as 5 mg tablets for oral use.', 'armGroupLabels': ['Ruxolitinib']}, {'name': 'Best Available Therapy (BAT)', 'type': 'DRUG', 'description': "BAT was based on the investigator's best judgment, taking into account the manufacturer's instructions, labeling, patient's medical condition, and institutional guidelines for any dose adjustment. The BAT in this study was identified by the investigator prior to patient randomization among the following treatments currently used in this setting: anti-thymocyte globulin (ATG), extracorporeal photopheresis (ECP), mesenchymal stromal cells (MSC), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), etanercept, or infliximab. No other types or combinations of BAT were permitted.", 'armGroupLabels': ['Best Available Therapy (BAT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '3002', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6150', 'city': 'Murdoch', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': 'A-4010', 'city': 'Linz', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1797', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.41117, 'lon': 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