Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-03 @ 10:13 PM
Study NCT ID:
NCT00482703
Status:
COMPLETED
Last Update Posted:
2010-12-17
First Post:
2007-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069439', 'term': 'Dasatinib'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'BMS Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dasatinib 100 mg Once-daily (QD) Starting Dose', 'description': 'Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.', 'otherNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Dasatinib 50 mg Twice-daily (BID) Starting Dose', 'description': 'Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.', 'otherNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Total', 'otherNumAtRisk': 23, 'otherNumAffected': 23, 'seriousNumAtRisk': 23, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Eustachian tube obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Eye disorders'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Eye disorders'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG001', 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{'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Oedema mouth', 'stats': [{'groupId': 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'numAffected': 9}], 'organSystem': 'Investigations'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 6}], 'organSystem': 'Investigations'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 5}], 'organSystem': 'Investigations'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 5}], 'organSystem': 'Investigations'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Red blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 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{'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Electrocardiogram QT corrected interval prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Blood calcium decreased', 'stats': 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{'term': 'Lymphocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Protein total increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Vitamin B12 decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 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{'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Histiocytosis haematophagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 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'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 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'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Glucose tolerance impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant 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'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '92', 'groupId': 'OG003', 'lowerLimit': '61.5', 'upperLimit': '99.8'}, {'value': '86', 'groupId': 'OG004', 'lowerLimit': '42.1', 'upperLimit': '99.6'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '47.8', 'upperLimit': '100.0'}]}]}, {'title': 'CCyR', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '61.0'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '57.9'}, {'value': '50', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '58', 'groupId': 'OG003', 'lowerLimit': '27.7', 'upperLimit': '84.8'}, {'value': '43', 'groupId': 'OG004', 'lowerLimit': '9.9', 'upperLimit': '81.6'}, {'value': '80', 'groupId': 'OG005', 'lowerLimit': '28.4', 'upperLimit': '99.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Cytogenetic responses (CyR) are based on the percentage of Philadelphia-positive (Ph+) metaphases among 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Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), and Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations, and Deaths During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'classes': [{'title': 'AEs (symptoms/signs and laboratory abnormalities)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'SAEs (symptoms/signs and laboratory abnormalities)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs that led to discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout study period to last observation. Dosing period=6 months; if beneficial, medication may continue in the extension period (ending in January 2009). Last observation=30 days past last dosing day or the discontinuation day.', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Complete Hematologic Response (CHR) in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 100 mg QD Starting Dose - Imatinib-resistant', 'description': 'Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG002', 'title': 'Dasatinib 100 mg QD Starting Dose - Imatinib-intolerant', 'description': 'Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG003', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG004', 'title': 'Dasatinib 50 mg BID Starting Dose - Imatinib-resistant', 'description': 'Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG005', 'title': 'Dasatinib 50 mg BID Starting Dose - Imatinib-intolerant', 'description': 'Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '99.8'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '42.1', 'upperLimit': '99.6'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '39.8', 'upperLimit': '100.0'}, {'value': '83', 'groupId': 'OG003', 'lowerLimit': '51.6', 'upperLimit': '97.9'}, {'value': '86', 'groupId': 'OG004', 'lowerLimit': '42.1', 'upperLimit': '99.6'}, {'value': '80', 'groupId': 'OG005', 'lowerLimit': '28.4', 'upperLimit': '99.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \\< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \\< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils \\< 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Time to Major Cytogenetic Response (MCyR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '5.6'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '5.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met', 'description': 'Time to MCyR is defined as the time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met. MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Ph+ Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants - responders'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of Dasatinib (BMS-354825) as Characterized by Population Pharmacokinetics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'paramType': 'NUMBER', 'timeFrame': 'Six or more peripheral blood samples were collected at any visit after Day 7, pre-dose and 5 - 8 hours after dose administration.', 'description': 'Blood sample collection for pharmacokinetic (PK) analysis that will contribute to PK modeling.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples were collected for PK to be included in separate population PK analyses. No study specific PK analyses were planned for this report.'}, {'type': 'SECONDARY', 'title': 'Duration of MCyR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'paramType': 'MEDIAN', 'timeFrame': 'from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death', 'description': 'The duration of MCyR will be measured from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death. Subjects who neither progress nor die will be censored on the date of their last cytogenetic assessment.MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Philadelphia-positive (Ph+) Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Median duration was not reached at the time of this report; see Outcome Measure 14 for corresponding life table.'}, {'type': 'SECONDARY', 'title': 'Time to CHR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.1'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '0.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'time from first dose of Dasatinib (BMS-354825) until the first day CHR criteria are met', 'description': 'Time to CHR = time from first dose of Dasatinib until the first day CHR criteria are met (provided subjects achieved a cCHR). CHR=all of the following criteria: white blood cell count ≤ upper limit of normal; platelets \\<450,000/mm³; no blasts or promyelocytes in peripheral blood; \\<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils \\<20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants - responders'}, {'type': 'SECONDARY', 'title': 'Duration of CHR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'paramType': 'MEDIAN', 'timeFrame': 'measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death', 'description': 'The duration of CHR were measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death. Subjects who neither progress nor die were censored on the date of their last hematologic assessment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Median duration of CHR was not reach at the time of this report. See corresponding life table presented in Outcome Measure 15.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'paramType': 'MEDIAN', 'timeFrame': 'time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met', 'description': 'Progressed disease=achieving a CHR \\& subsequently no longer meeting criteria consistently over a consecutive 2-week period after starting maximum dose; no CHR after receiving maximum dose \\& increase in white blood cell count (doubling of count from lowest value to \\>20,000/mm3 or an increase by \\>50,000/mm3 on 2 assessments done ≥2 weeks apart); meeting the criteria of accelerated or blastic phase chronic myeloid leukemia at any time; having an MCyR \\& subsequently no longer meeting the criteria for MCyR after starting maximum dose; or having a \\>=30% absolute increase in number of Ph+ metaphases.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Median months of progression-free survival was not reached at the time of this report. See corresponding life table in Outcome Measure 16.'}, {'type': 'SECONDARY', 'title': 'Expression of BCR-ABL Gene Mutations of RNA (mRNA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'classes': [{'title': 'Positive at Baseline', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Negative at Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Positive at End-of-Study', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Negative at End-of-Study', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)', 'description': 'Number of participants with positive (\\>= 2.0 log copies/mg) and negative (\\<2.0 log copies/mg) expression of mRNA at Baseline and at end of study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants'}, {'type': 'SECONDARY', 'title': 'Mutational Spectrum of BCR-ABL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'classes': [{'title': 'G250E mutation at Baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'G250E mutation at End-of-Study', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'F317L mutation at Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'F317L mutation at End-of-Study', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'T315I mutation at Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'T315I mutation at End-of-Study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)', 'description': 'Number of participants with a particular BCR-ABL mutation at Baseline and End-of-Study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants'}, {'type': 'SECONDARY', 'title': 'Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'classes': [{'title': 'MCyR', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '23.4', 'upperLimit': '83.3'}, {'value': '92', 'groupId': 'OG001', 'lowerLimit': '61.5', 'upperLimit': '99.8'}]}]}, {'title': 'CCyR', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '69.2'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '34.9', 'upperLimit': '90.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)', 'description': 'Cytogenetic response (CyR) as reflected in the major cytogenetic response was determined by bone marrow (BM) aspirates and are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each BM sample. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), or Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Hematologic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '99.8'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '51.6', 'upperLimit': '97.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)', 'description': 'CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \\< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \\< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils \\< 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Major Cytogenetic Response at Months 0 - 24 (Duration of MCyR Life Table)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'classes': [{'title': 'Month 0', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Month 8', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Month 16', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Month 20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 0, 4, 8, 12, 16, 20, 24', 'description': 'MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Ph+ Cells in Metaphase in BM: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 6)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With CHR at Months 0 - 24 (Duration of MCyR Life Table)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'classes': [{'title': 'Month 0', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Month 8', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Month 16', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Month 20', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 0, 4, 8, 12, 16, 20, 24', 'description': 'CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \\< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \\< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils \\< 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 7)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Progression-Free Survival (PFS) at Months 0 - 24 (PFS Life Table)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib 100 mg QD Starting Dose Cohort', 'description': 'All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.'}, {'id': 'OG001', 'title': 'Dasatinib 50 mg BID Starting Dose Cohort', 'description': 'All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.'}], 'classes': [{'title': 'Month 0', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Month 8', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Month 16', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Month 20', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 0, 4, 8, 12, 16, 20, 24', 'description': 'Progressed disease=achieving a CHR and subsequently no longer meeting criteria consistently over a consecutive 2-week period after starting maximum dose; no CHR after receiving maximum dose and an increase in white blood cell count (doubling of the count from lowest value to \\>20,000/mm3 or an increase by \\>50,000/mm3 on 2 assessments done at least 2 weeks apart); meeting the criteria of accelerated or blastic phase CML at any time; having an MCyR and subsequently no longer meeting the criteria for MCyR after starting maximum dose; or having a \\>=30% absolute increase in number of Ph+ metaphases.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 7)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dasatinib 100 mg Once-daily (QD) Starting Dose', 'description': 'Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.'}, {'id': 'FG001', 'title': 'Dasatinib 50 mg Twice-daily (BID) Starting Dose', 'description': 'Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'number enrolled, randomized and treated', 'groupId': 'FG000', 'numSubjects': '11'}, {'comment': 'number enrolled, randomized and treated', 'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Poor compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dasatinib 100 mg Once-daily (QD) Starting Dose', 'description': 'Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.'}, {'id': 'BG001', 'title': 'Dasatinib 50 mg Twice-daily (BID) Starting Dose', 'description': 'Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '49.9', 'spread': '16.0', 'groupId': 'BG001'}, {'value': '49.3', 'spread': '14.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Eastern Cooperative Oncology Group Performace Status (ECOG-PS)', 'classes': [{'title': 'Status=0', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Status=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Status=2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Status=3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Status=4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Status=5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'ECOG PS scale is a 6-item scale to assess disease progression, daily functioning, and appropriate treatment and prognosis. Scale=0-5, with 0=fully active, 1=restricted in physically strenuous activity but ambulatory, 2=ambulatory and capable of all selfcare but unable to work, 3= limited selfcare ability and confined to bed/chair \\>50% of waking hours, 4=completely disabled and no selfcare ability and confined to bed/chair, and 5=death', 'unitOfMeasure': 'participants'}, {'title': 'Imatinib Status', 'classes': [{'title': 'Imatinib-resistant', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Imatinib-intolerant', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Resistance to Imatinib=Previously treated with imatinib at a dose of ≥ 400 mg/day AND developed progressive disease while receiving imatinib at that dose. Intolerance to Imatinib=development of a Grade ≥3 toxicity considered at least possibly related to imatinib at a dose of ≤400 mg/day which led to discontinuation of therapy.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-30', 'studyFirstSubmitDate': '2007-06-04', 'resultsFirstSubmitDate': '2010-07-23', 'studyFirstSubmitQcDate': '2007-06-04', 'lastUpdatePostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-02', 'studyFirstPostDateStruct': {'date': '2007-06-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Major Cytogenetic Response at Months 0 - 24 (Duration of MCyR Life Table)', 'timeFrame': 'Months 0, 4, 8, 12, 16, 20, 24', 'description': 'MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Ph+ Cells in Metaphase in BM: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35'}, {'measure': 'Number of Participants With CHR at Months 0 - 24 (Duration of MCyR Life Table)', 'timeFrame': 'Months 0, 4, 8, 12, 16, 20, 24', 'description': 'CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \\< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \\< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils \\< 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.'}, {'measure': 'Number of Participants With Progression-Free Survival (PFS) at Months 0 - 24 (PFS Life Table)', 'timeFrame': 'Months 0, 4, 8, 12, 16, 20, 24', 'description': 'Progressed disease=achieving a CHR and subsequently no longer meeting criteria consistently over a consecutive 2-week period after starting maximum dose; no CHR after receiving maximum dose and an increase in white blood cell count (doubling of the count from lowest value to \\>20,000/mm3 or an increase by \\>50,000/mm3 on 2 assessments done at least 2 weeks apart); meeting the criteria of accelerated or blastic phase CML at any time; having an MCyR and subsequently no longer meeting the criteria for MCyR after starting maximum dose; or having a \\>=30% absolute increase in number of Ph+ metaphases.'}], 'primaryOutcomes': [{'measure': 'Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24', 'timeFrame': 'Week 24', 'description': 'Cytogenetic responses (CyR) are based on the percentage of Philadelphia-positive (Ph+) metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), and Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).'}], 'secondaryOutcomes': [{'measure': 'Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations, and Deaths During Treatment', 'timeFrame': 'Throughout study period to last observation. Dosing period=6 months; if beneficial, medication may continue in the extension period (ending in January 2009). Last observation=30 days past last dosing day or the discontinuation day.', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.'}, {'measure': 'Complete Hematologic Response (CHR) in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24', 'timeFrame': 'Week 24', 'description': 'CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \\< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \\< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils \\< 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.'}, {'measure': 'Time to Major Cytogenetic Response (MCyR)', 'timeFrame': 'time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met', 'description': 'Time to MCyR is defined as the time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met. MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Ph+ Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35'}, {'measure': 'Pharmacokinetics of Dasatinib (BMS-354825) as Characterized by Population Pharmacokinetics', 'timeFrame': 'Six or more peripheral blood samples were collected at any visit after Day 7, pre-dose and 5 - 8 hours after dose administration.', 'description': 'Blood sample collection for pharmacokinetic (PK) analysis that will contribute to PK modeling.'}, {'measure': 'Duration of MCyR', 'timeFrame': 'from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death', 'description': 'The duration of MCyR will be measured from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death. Subjects who neither progress nor die will be censored on the date of their last cytogenetic assessment.MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Philadelphia-positive (Ph+) Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35'}, {'measure': 'Time to CHR', 'timeFrame': 'time from first dose of Dasatinib (BMS-354825) until the first day CHR criteria are met', 'description': 'Time to CHR = time from first dose of Dasatinib until the first day CHR criteria are met (provided subjects achieved a cCHR). CHR=all of the following criteria: white blood cell count ≤ upper limit of normal; platelets \\<450,000/mm³; no blasts or promyelocytes in peripheral blood; \\<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils \\<20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.'}, {'measure': 'Duration of CHR', 'timeFrame': 'measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death', 'description': 'The duration of CHR were measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death. Subjects who neither progress nor die were censored on the date of their last hematologic assessment.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met', 'description': 'Progressed disease=achieving a CHR \\& subsequently no longer meeting criteria consistently over a consecutive 2-week period after starting maximum dose; no CHR after receiving maximum dose \\& increase in white blood cell count (doubling of count from lowest value to \\>20,000/mm3 or an increase by \\>50,000/mm3 on 2 assessments done ≥2 weeks apart); meeting the criteria of accelerated or blastic phase chronic myeloid leukemia at any time; having an MCyR \\& subsequently no longer meeting the criteria for MCyR after starting maximum dose; or having a \\>=30% absolute increase in number of Ph+ metaphases.'}, {'measure': 'Expression of BCR-ABL Gene Mutations of RNA (mRNA)', 'timeFrame': 'Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)', 'description': 'Number of participants with positive (\\>= 2.0 log copies/mg) and negative (\\<2.0 log copies/mg) expression of mRNA at Baseline and at end of study.'}, {'measure': 'Mutational Spectrum of BCR-ABL', 'timeFrame': 'Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)', 'description': 'Number of participants with a particular BCR-ABL mutation at Baseline and End-of-Study.'}, {'measure': 'Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study', 'timeFrame': 'Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)', 'description': 'Cytogenetic response (CyR) as reflected in the major cytogenetic response was determined by bone marrow (BM) aspirates and are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each BM sample. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), or Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).'}, {'measure': 'Hematologic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study', 'timeFrame': 'Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)', 'description': 'CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \\< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \\< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils \\< 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Imatinib resistant or intolerant chronic phase CML'], 'conditions': ['Myeloid Leukemia, Chronic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The objective is to evaluate the cytogenetic response to Dasatinib (BMS-354825) administered for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase chronic myeloid leukemia (CML) once daily (QD) or twice daily. (BID)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Philadelphia chromosome positive or bcr-abl gene positive Chronic phase Chronic Myelogenous Leukemia (CML) subjects must have primary or acquired resistance to Imatinib mesylate or have intolerance of imatinib mesylate\n* Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2\n* Men and women, ages 20 to 75\n* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized\n\nExclusion Criteria:\n\n* Subjects who are eligible and willing to undergo transplantation at pre-study\n* Women who are pregnant or breastfeeding\n* Uncontrolled or significant cardiovascular disease\n* History of significant bleeding disorder unrelated to CML\n* Adequate hepatic function\n* Adequate renal function\n* Medication that increases bleeding risk\n* Medication that changes heart rhythms\n* Subjects who are compulsory detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study'}, 'identificationModule': {'nctId': 'NCT00482703', 'briefTitle': 'A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Multicenter, Open-label Phase II Study of Dasatinib (BMS-354825) Administered Orally at a Dose of 50mg Twice Daily or 100mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia Who Are Resistant or Intolerant to Imatinib', 'orgStudyIdInfo': {'id': 'CA180-138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: Dasatinib']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: dasatinib']}], 'interventions': [{'name': 'Dasatinib', 'type': 'DRUG', 'otherNames': ['Sprycel', 'BMS-354825'], 'description': 'tablets, Oral, 100 mg, once daily', 'armGroupLabels': ['A']}, {'name': 'dasatinib', 'type': 'DRUG', 'otherNames': ['Sprycel', 'BMS-354825'], 'description': 'tablets, Oral, 50 mg, twice daily', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '464-8681', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '663-8501', 'city': 'Nishinomiya-Shi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '890-0064', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '259-1193', 'city': 'Isehara-Shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Local Institution'}, {'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '431-3192', 'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'zip': '113-8677', 'city': 'Bunkyo-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '104-0045', 'city': 'Chuo-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '150-8935', 'city': 'Shibuya-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}