Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-03 @ 6:25 PM
Study NCT ID:
NCT02195869
Status:
COMPLETED
Last Update Posted:
2019-07-11
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551803', 'term': 'ibrutinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mjuretic@pcyc.com', 'phone': '(408) 215.3628', 'title': 'Manuela Juretic, Associate Director, Clinical Operations', 'organization': 'Pharmacyclics LLC, An AbbVie Company'}, 'certainAgreement': {'otherDetails': 'Institution/Investigator will not publish without Sponsor prior review and approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug to within 30 days of last dose or starting subsequent therapy for cGVHD, up to 36.7 months', 'description': 'Adverse events were not collected by phase because the phase 1 part of the study confirmed the first dose level (420mg was acceptable for cGVHD subjects and it was used as the recommended Phase 2 dose (RP2D). The Safety Population was the same as the All-treated Population (ie, all subject who received at least 1 dose of ibrutinib at the RP2D)', 'eventGroups': [{'id': 'EG000', 'title': 'Phase1b/Phase 2', 'description': 'Subjects receive daily dose of 420 mg of Ibrutinib capsules', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 41, 'seriousNumAtRisk': 42, 'deathsNumAffected': 7, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Blood and lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardiac Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Mouth Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastroesophogeal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fatique', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hepatobiliary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 6}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neoplasms benign, malignant unspecified (incl cysts and polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Delerium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Night Sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Atrial fibrilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Brain abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Graft versus host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Prolymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Skin mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Dose Level 1', 'description': 'Subjects receive daily dose of 420 mg of Ibrutinib capsules for dose level 1'}, {'id': 'OG001', 'title': 'Phase 2', 'description': 'Subjects receive daily dose of 420 mg of Ibrutinib capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 treatment days after last subject enrolled in Phase 1 dose level(s).', 'description': 'Number of participants with dose-limiting toxicities as a measure of safety profile to determine recommended dose of ibrutinib', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Endpoint only includes Phase 1 data.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Overall Response Rate as the Percentage of Participants With Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase1b/Phase 2', 'description': 'Subjects receive daily dose of 420 mg of Ibrutinib capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '52.9', 'upperLimit': '82.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.', 'description': 'Overall Response Rate is defined as the proportion of subjects who achieved complete response (CR) or partial response (PR). Response criteria are based on NIH cGVHD Response assessment (Pavletic 2006; Measurement of Therapeutic Response, ASBMT Web site).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed using the All-treated Population (N = 42)'}, {'type': 'SECONDARY', 'title': 'Sustained Response Rate as the Percentage of Participants With Sustained Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase1b/Phase 2', 'description': 'Subjects receive daily dose of 420 mg of Ibrutinib capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '49.2', 'upperLimit': '84.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.', 'description': 'For subjects who achieved an NIH-defined CR or PR, the proportion of subjects who achieved CR or PR that was sustained for at least 20 weeks (140 days). Intermittent SD was also acceptable.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 subjects include all subjects who participated in phase 1b. Subjects evaluated for sustained response includes participants who had achieved an NIH-defined CR or PR.'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase1b/Phase 2', 'description': 'Subjects receive daily dose of 420 mg of Ibrutinib capsules'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA means not achieved or not estimable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.', 'description': 'For subjects who achieved an NIH-defined CR or PR, the interval between the date of initial documentation of a response and the date of first documented evidence of PD, death, or date of censoring if applicable.', 'unitOfMeasure': 'Median', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 subjects includes all subjects who participated in Phase 1b'}, {'type': 'SECONDARY', 'title': 'Corticosteroid Requirement Changes Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b/Phase 2', 'description': 'Subjects receive daily dose of 420 mg of Ibrutinib capsules'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.31', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '1.3'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '1.35'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '1.35'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.31', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '1.35'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.31', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '1.53'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '1.53'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '1.53'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '1.53'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '1.03'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '1.54'}]}]}, {'title': 'Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.02'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.62'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.24', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.62'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.57'}]}]}, {'title': 'Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.58'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.48'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.47'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.44'}]}]}, {'title': 'Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.44'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.44'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.37'}]}]}, {'title': 'Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.37'}]}]}, {'title': 'Week 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.60'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.37'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.38'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.37'}]}]}, {'title': 'Week 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.37'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.37'}]}]}, {'title': 'Week 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.37'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.32'}]}]}, {'title': 'Week 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.29'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.29'}]}]}, {'title': 'Week 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.29'}]}]}, {'title': 'Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.29'}]}]}, {'title': 'Week 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.29'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.29'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.29'}]}]}, {'title': 'Week 38', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.35'}]}]}, {'title': 'Week 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.30'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.30'}]}]}, {'title': 'Week 41', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.30'}]}]}, {'title': 'Week 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.30'}]}]}, {'title': 'Week 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.30'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.60'}]}]}, {'title': 'Week 47', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.60'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.53'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.46'}]}]}, {'title': 'Week 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.36'}]}]}, {'title': 'Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.24'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.24'}]}]}, {'title': 'Week 53', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.24'}]}]}, {'title': 'Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.24'}]}]}, {'title': 'Week 55', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.24'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.24'}]}]}, {'title': 'Week 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.24'}]}]}, {'title': 'Week 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.27'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 63', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 67', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 69', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.21'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 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'upperLimit': '0.95'}]}]}, {'title': 'Week 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 93', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 94', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 98', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 101', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': 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'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 109', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 111', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': 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'upperLimit': '0.95'}]}]}, {'title': 'Week 116', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 117', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 118', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 119', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.95'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 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'upperLimit': '0.16'}]}]}, {'title': 'Week 142', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.17'}]}]}, {'title': 'Week 143', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.17'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.17'}]}]}, {'title': 'Week 145', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.17'}]}]}, {'title': 'Week 146', 'denoms': [{'units': 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[{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.17'}]}]}, {'title': 'Week 151', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.17'}]}]}, {'title': 'Week 152', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.17'}]}]}, {'title': 'Week 153', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.15'}]}]}, {'title': 'Week 154', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.14'}]}]}, {'title': 'Week 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.14'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.14'}]}]}, {'title': 'Week 157', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.13'}]}]}, {'title': 'Week 158', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.11'}]}]}, {'title': 'Week 159', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.11'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.', 'description': 'Average daily corticosteroid dose assessed each week.', 'unitOfMeasure': 'Daily Dose of Steroid by Weight (mg/kg/d', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 subjects includes all subjects who participated in Phase 1b.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b/Phase 2', 'description': 'Subjects receive daily dose of 420 mg of Ibrutinib capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '59'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.', 'description': 'Subject reported improvement in symptom burden. The symptom burden will be measured according to the Lee cGVHD Symptom Scale. A change in \\>7 points on the Lee cGVHD Symptom Scale will be considered significant and relates to improvement in quality of life.\n\nA score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. A total summary score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores.\n\nThere are 7 subscales (Skin, Energy, Lung, Eye, Nutrition, Mouth and Psychological) with ratings as follow: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely; with a lower values representing a better outcome.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of ibrutinib at the recommended Phase 2 dose.'}, {'type': 'SECONDARY', 'title': 'Phase 2b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b/Phase 2', 'description': 'Subjects receive daily dose of 420 mg of Ibrutinib capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose with study drug until 30 days after the last dose of study drug, up to 36.7 months', 'description': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 subjects includes all subjects who participated in Phase 1b'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1b/Phase 2', 'description': 'Subjects receive daily dose of 420 mg of Ibrutinib capsules'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Phase 1b: 6 patients, 420 mg, no DLT observed. Phase 2: 42 patients, 420 mg', 'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'All-Treated Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'cGVHD Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Malignancy Progression/relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Noncompliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1b/Phase 2', 'description': 'Subjects receive daily dose of 420 mg of Ibrutinib capsules'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'spread': '15.53', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline analysis population includes all participants that received at least 1 dose of ibrutinib.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-21', 'size': 1707620, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-30T14:06', 'hasProtocol': True}, {'date': '2016-08-31', 'size': 280959, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-30T14:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-14', 'studyFirstSubmitDate': '2014-07-11', 'resultsFirstSubmitDate': '2019-04-30', 'studyFirstSubmitQcDate': '2014-07-16', 'lastUpdatePostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-14', 'studyFirstPostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD.', 'timeFrame': '28 treatment days after last subject enrolled in Phase 1 dose level(s).', 'description': 'Number of participants with dose-limiting toxicities as a measure of safety profile to determine recommended dose of ibrutinib'}, {'measure': 'Phase 2: Overall Response Rate as the Percentage of Participants With Response', 'timeFrame': 'Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.', 'description': 'Overall Response Rate is defined as the proportion of subjects who achieved complete response (CR) or partial response (PR). Response criteria are based on NIH cGVHD Response assessment (Pavletic 2006; Measurement of Therapeutic Response, ASBMT Web site).'}], 'secondaryOutcomes': [{'measure': 'Sustained Response Rate as the Percentage of Participants With Sustained Response', 'timeFrame': 'Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.', 'description': 'For subjects who achieved an NIH-defined CR or PR, the proportion of subjects who achieved CR or PR that was sustained for at least 20 weeks (140 days). Intermittent SD was also acceptable.'}, {'measure': 'To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR)', 'timeFrame': 'Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.', 'description': 'For subjects who achieved an NIH-defined CR or PR, the interval between the date of initial documentation of a response and the date of first documented evidence of PD, death, or date of censoring if applicable.'}, {'measure': 'Corticosteroid Requirement Changes Over Time', 'timeFrame': 'Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.', 'description': 'Average daily corticosteroid dose assessed each week.'}, {'measure': 'Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Summary Score', 'timeFrame': 'Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.', 'description': 'Subject reported improvement in symptom burden. The symptom burden will be measured according to the Lee cGVHD Symptom Scale. A change in \\>7 points on the Lee cGVHD Symptom Scale will be considered significant and relates to improvement in quality of life.\n\nA score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. A total summary score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores.\n\nThere are 7 subscales (Skin, Energy, Lung, Eye, Nutrition, Mouth and Psychological) with ratings as follow: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely; with a lower values representing a better outcome.'}, {'measure': 'Phase 2b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD', 'timeFrame': 'From first dose with study drug until 30 days after the last dose of study drug, up to 36.7 months', 'description': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib'}]}, 'conditionsModule': {'keywords': ['PCYC1129', 'PCYC1129CA', '1129', 'Ibrutinib', 'PCI32765', 'IMBRUVICA', 'Pharmacyclics', 'PCYC', 'GVHD', 'Steroid dependent', 'refractory', 'chronic', 'graft versus host disease', 'chronic graft versus host disease', 'immunology'], 'conditions': ['Graft Versus Host Disease']}, 'referencesModule': {'references': [{'pmid': '34102349', 'type': 'DERIVED', 'citation': 'Doki N, Toyosaki M, Shiratori S, Osumi T, Okada M, Kawakita T, Sawa M, Ishikawa T, Ueda Y, Yoshinari N, Nakahara S. An Open-Label, Single-Arm, Multicenter Study of Ibrutinib in Japanese Patients With Steroid-dependent/Refractory Chronic Graft-Versus-Host Disease. Transplant Cell Ther. 2021 Oct;27(10):867.e1-867.e9. doi: 10.1016/j.jtct.2021.05.019. Epub 2021 Jun 6.'}, {'pmid': '31260802', 'type': 'DERIVED', 'citation': 'Waller EK, Miklos D, Cutler C, Arora M, Jagasia MH, Pusic I, Flowers MED, Logan AC, Nakamura R, Chang S, Clow F, Lal ID, Styles L, Jaglowski S. Ibrutinib for Chronic Graft-versus-Host Disease After Failure of Prior Therapy: 1-Year Update of a Phase 1b/2 Study. Biol Blood Marrow Transplant. 2019 Oct;25(10):2002-2007. doi: 10.1016/j.bbmt.2019.06.023. Epub 2019 Jun 28.'}, {'pmid': '28924018', 'type': 'DERIVED', 'citation': 'Miklos D, Cutler CS, Arora M, Waller EK, Jagasia M, Pusic I, Flowers ME, Logan AC, Nakamura R, Blazar BR, Li Y, Chang S, Lal I, Dubovsky J, James DF, Styles L, Jaglowski S. Ibrutinib for chronic graft-versus-host disease after failure of prior therapy. Blood. 2017 Nov 23;130(21):2243-2250. doi: 10.1182/blood-2017-07-793786. Epub 2017 Sep 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and clinical efficacy of ibrutinib in subjects with steroid dependent or refractory Chronic Graft Versus Host Disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Steroid dependent or refractory classic chronic GVHD disease.\n* No more than 3 previous treatments for cGVHD.\n* Receiving baseline systemic glucocorticoid therapy (at stable dose) for cGVHD at study entry.\n* Men and women ≥18 years old.\n* Karnofsky performance status ≥60.\n\nExclusion Criteria:\n\n* Known or suspected active acute GVHD.\n* Current treatment with sirolimus AND either cyclosporine or tacrolimus.\n* History of treatment with a tyrosine kinase inhibitor (eg, imatinib), purine analogs or other cancer chemotherapy in the 4 weeks prior to starting study drug.\n* Currently active, clinically significant cardiovascular disease.\n* Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines or a recent infection requiring systemic treatment that was completed ≤14 days before the first dose of study drug.\n* Progressive underlying malignant disease including post-transplant lymphoproliferative disease.\n* History of other malignancy (not including the underlying malignancy that was the indication for transplant)\n* Concomitant use of warfarin or other Vitamin K antagonists\n* Known bleeding disorders or hemophilia.\n* History of stroke or intracranial hemorrhage within 6 months prior to enrollment.\n* Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV).\n* Concurrent use of a strong cytochrome P450(CYP) 3A inhibitor.'}, 'identificationModule': {'nctId': 'NCT02195869', 'briefTitle': "Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmacyclics LLC.'}, 'officialTitle': 'A Multicenter Open-Label Phase 1b/2 Study of Ibrutinib in Steroid Dependent or Refractory Chronic Graft Versus Host Disease', 'orgStudyIdInfo': {'id': 'PCYC-1129-CA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1b: Dose Level 1', 'description': 'Subjects receive daily dose of 420 mg of Ibrutinib capsules', 'interventionNames': ['Drug: Ibrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b: Dose Level 2', 'description': 'Subjects receive daily dose of 280 mg of Ibrutinib capsules', 'interventionNames': ['Drug: Ibrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b: Dose Level 3', 'description': 'Subjects receive daily dose of 140 mg of Ibrutinib capsules', 'interventionNames': ['Drug: Ibrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2', 'description': 'Subjects receive daily dose of recommended phase 2 dose', 'interventionNames': ['Drug: Ibrutinib']}], 'interventions': [{'name': 'Ibrutinib', 'type': 'DRUG', 'otherNames': ['PCI32765'], 'armGroupLabels': ['Phase 1b: Dose Level 1', 'Phase 1b: Dose Level 2', 'Phase 1b: Dose Level 3', 'Phase 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University, Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center, Henry-Joyce Cancer Clinic', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Lori Styles, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pharmacyclics LLC.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmacyclics LLC.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}