Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT01030718
Status:
COMPLETED
Last Update Posted:
2010-12-14
First Post:
2009-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Rollover Study of BMS-354825 in Patients With CML and Ph+ALL
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': 'All Treated Participants', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort, Imatinib resistant or intolerant CML-AP/BP disease cohort, and Ph+ ALL subjects with resistance or intolerance to past therapy. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.', 'otherNumAtRisk': 54, 'otherNumAffected': 54, 'seriousNumAtRisk': 54, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Cardiac disorders'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Cardiac disorders'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Cardiac disorders'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Cardiac disorders'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Endocrine disorders'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 10}], 'organSystem': 'Eye disorders'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Eye disorders'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Eye disorders'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Eye disorders'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Eye disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gingival swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 27}], 'organSystem': 'General disorders'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 23}], 'organSystem': 'General disorders'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 18}], 'organSystem': 'General disorders'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 9}], 'organSystem': 'General disorders'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'General disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'General disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Immune system disorders'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 29}], 'organSystem': 'Infections and infestations'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Infections and infestations'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 46}], 'organSystem': 'Investigations'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 42}], 'organSystem': 'Investigations'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 41}], 'organSystem': 'Investigations'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 39}], 'organSystem': 'Investigations'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 39}], 'organSystem': 'Investigations'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 35}], 'organSystem': 'Investigations'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 34}], 'organSystem': 'Investigations'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 30}], 'organSystem': 'Investigations'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 25}], 'organSystem': 'Investigations'}, {'term': 'Haematocrit decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 25}], 'organSystem': 'Investigations'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 25}], 'organSystem': 'Investigations'}, {'term': 'Red blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 24}], 'organSystem': 'Investigations'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 24}], 'organSystem': 'Investigations'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 23}], 'organSystem': 'Investigations'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 23}], 'organSystem': 'Investigations'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 22}], 'organSystem': 'Investigations'}, {'term': 'Protein total decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 20}], 'organSystem': 'Investigations'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 19}], 'organSystem': 'Investigations'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 18}], 'organSystem': 'Investigations'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 17}], 'organSystem': 'Investigations'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 17}], 'organSystem': 'Investigations'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 16}], 'organSystem': 'Investigations'}, {'term': 'CD4 lymphocytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 16}], 'organSystem': 'Investigations'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 12}], 'organSystem': 'Investigations'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 10}], 'organSystem': 'Investigations'}, {'term': 'Urinary sediment abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 10}], 'organSystem': 'Investigations'}, {'term': 'Reticulocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 9}], 'organSystem': 'Investigations'}, {'term': 'Urobilin urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 9}], 'organSystem': 'Investigations'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Investigations'}, {'term': 'Electrocardiogram QT corrected interval prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Investigations'}, {'term': 'Glucose urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Investigations'}, {'term': 'Protein urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Investigations'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Investigations'}, {'term': 'Blood magnesium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Investigations'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Investigations'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Investigations'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Investigations'}, {'term': 'Lymphocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}], 'organSystem': 'Investigations'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Investigations'}, {'term': 'CD4 lymphocytes increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Investigations'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Prothrombin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Reticulocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Platelet count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Blood chloride decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Eosinophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Urine ketone body present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 26}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Nervous system disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Gynaecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Haemorrhage subcutaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Therapeutic response decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}], 'organSystem': 'Infections and infestations'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Perianal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pseudomembranous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Brain herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Drug toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Haematocrit decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Red blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Acute lymphocytic leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Tumour lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Blast cell crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Brain mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Chronic Phase (CML-CP)', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG002', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'title': 'AEs (symptoms/signs and laboratory abnormalities)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'SAEs (symptoms/signs and laboratory abnormalities)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'AEs that led to discontinuation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline; every 4 weeks (if on study < 6 months, including CA180-031(NCT00337454); every 12 weeks (if on study >=6 months and <=2 years); every 24 weeks (if on study >2 years); at discontinuation', '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 development of drug dependency or drug abuse, is an important medical event.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants. Number of deaths represents all reported deaths, including after the study end. For AEs leading to discontinuation: 4 in CML-CP=1 insufficient effect (IE) +3 AEs in Participant Flow (PF); 7 in CML-AP/BP= 1 death + 5 AEs + 1 IE in PF; 4 in Ph+ALL=3 IE + 1AE in PF.'}, {'type': 'SECONDARY', 'title': 'Participants With Chronic Phase CML (CML-CP): Percentage of Participants With Cytogenetic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Chronic Phase (CML-CP) Total', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'CML - Chronic Phase (CML-CP) - Imatinib Resistant', 'description': 'Imatinib resistant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG002', 'title': 'CML - Chronic Phase (CML-CP) - Imatinib Intolerant', 'description': 'Imatinib intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'title': 'Major cytogenetic response (MCyR)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '57.7', 'upperLimit': '90.1'}, {'value': '61', 'groupId': 'OG001', 'lowerLimit': '35.7', 'upperLimit': '82.7'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '73.5', 'upperLimit': '100.0'}]}]}, {'title': 'Complete cytogenetic response (CCyR)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '43.9', 'upperLimit': '80.1'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '21.5', 'upperLimit': '69.2'}, {'value': '92', 'groupId': 'OG002', 'lowerLimit': '61.5', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)', 'description': 'Cytogenetic responses (CyR) are based on the percentage of 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), plus Partial Cytogenetic Response (PCyR; 1 - 35 Philadelphia positive \\[Ph+\\] Cells in Metaphase in BM).', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated CML-CP participants'}, {'type': 'SECONDARY', 'title': 'Participants With CML-Accelerated or Blast Phase (AP/BP): Percentage of Participants With Cytogenetic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CML-AP/BP - Total Cohort', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'CML-AP/BP - Imatinib Resistant', 'description': 'Imatinib resistant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG002', 'title': 'CML-AP/BP - Imatinib Intolerant', 'description': 'Imatinib intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'title': 'Major cytogenetic response (MCyR)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '61.0'}, {'value': '38', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '75.5'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Complete cytogenetic response (CCyR)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '51.8'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '65.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter', 'description': 'Cytogenetic responses (CyR) are based on the percentage of 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), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated CML-AP/BP participants'}, {'type': 'SECONDARY', 'title': 'Participants With Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL): Percentage of Participants With Cytogenetic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Total Cohort', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Resistant', 'description': 'Ph+ ALL subjects with resistance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG002', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Intolerant', 'description': 'Ph+ ALL subjects with intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'title': 'Major cytogenetic response (MCyR)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '25.1', 'upperLimit': '80.8'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '70.1'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '39.8', 'upperLimit': '100.0'}]}]}, {'title': 'Complete cytogenetic response (CCyR)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '74.9'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '60.0'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '39.8', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter', 'description': 'Cytogenetic responses (CyR) are based on the percentage of 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), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Ph+ ALL participants'}, {'type': 'SECONDARY', 'title': 'Participants With CML-CP: Time to Complete Cytogenetic Response (CCyR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Chronic Phase (CML-CP)', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '841'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454),', 'description': 'Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Time to complete CCyR is defined as the time from first dose of dasatinib until measurement criteria are first met for CCyR, and is computed only for subjects whose best response is CCyR.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants achieving CCyR'}, {'type': 'SECONDARY', 'title': 'Participants With CML-AP/BP and Ph+ ALL: Time to Complete Cytogenetic Response (CCyR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '337'}, {'value': '82', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '89'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter', 'description': 'Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Time to complete CCyR is defined as the time from first dose of dasatinib until measurement criteria are first met for CCyR, and is computed only for subjects whose best response is CCyR.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants achieving CCyR'}, {'type': 'SECONDARY', 'title': 'Participants With CML-CP: Duration of Complete Cytogenetic Response (CCyR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Chronic Phase (CML-CP)', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)', 'description': 'Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Duration of CCyR was measured from the time measurement criteria are first met for CCyR until the first date of progressed disease (PD) or death. Subjects who neither relapsed nor died will be censored on the date of their last assessment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants achieving CCyR. Median duration of CCyR was not yet reached in the CML-CP group.'}, {'type': 'SECONDARY', 'title': 'Participants With CML-AP/BP and Ph+ALL: Duration of Complete Cytogenetic Response (CCyR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.5', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '705'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter', 'description': 'Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Duration of CCyR was measured from the time measurement criteria are first met for CCyR until the first date of PD or death. Subjects who neither relapsed nor died will be censored on the date of their last assessment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants achieving CCyR. Median duration of CCyR was not yet reached in the CML-AP/BP group.'}, {'type': 'SECONDARY', 'title': 'Participants With CML-CP: Time to Major Cytogenetic Response (MCyR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Chronic Phase (CML-CP)', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '1006'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)', 'description': 'Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Time to MCyR was defined as the time from first dose of dasatinib until measurement criteria were first met for CCyR or PCyR (whichever status is recorded first).', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Time to MCyR was computed only for participants whose best response was CCyR or PCyR.'}, {'type': 'SECONDARY', 'title': 'Participants With CML-AP/BP and Ph+ALL: Time to Major Cytogenetic Response (MCyR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '93'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '96'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter', 'description': 'Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Time to MCyR was defined as the time from first dose of dasatinib until measurement criteria were first met for CCyR or PCyR (whichever status is recorded first).', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Time to MCyR was computed only for participants whose best response was CCyR or PCyR.'}, {'type': 'SECONDARY', 'title': 'Participants With CML-CP: Duration of Major Cytogenetic Response (MCyR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Chronic Phase (CML-CP)', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)', 'description': 'Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Duration of MCyR was measured from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the first date of progressive disease (PD) or death. Subjects who neither relapsed nor died were censored on the date of their last assessment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of MCyR was computed for subjects whose best response was either CCyR or PCyR. Median duration of MCyR was not yet reached in the CML-CP arm.'}, {'type': 'SECONDARY', 'title': 'Participants With CML-AP/BP and Ph+ ALL: Duration of Major Cytogenetic Response (MCyR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '705'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter', 'description': 'Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Duration of MCyR was measured from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the first date of progressive disease (PD) or death. Subjects who neither relapsed nor died were censored on the date of their last assessment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of MCyR was computed for subjects whose best response was either CCyR or PCyR. Median duration of MCyR was not yet reached in the CML-AP/BP arm.'}, {'type': 'SECONDARY', 'title': 'Participants With CML-CP: Percentage of Participants With Complete Hematologic Response (CHR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Chronic Phase (CML-CP) Total', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'CML - Chronic Phase (CML-CP) - Imatinib Resistant', 'description': 'Imatinib resistant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG002', 'title': 'CML - Chronic Phase (CML-CP) - Imatinib Intolerant', 'description': 'Imatinib intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '77.9', 'upperLimit': '99.2'}, {'value': '89', 'groupId': 'OG001', 'lowerLimit': '65.3', 'upperLimit': '98.6'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '73.5', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454), every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'CHR=all of the following criteria: white blood cell count (WBC) ≤institutional upper limit of normal(ULN); 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.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated CML-CP participants'}, {'type': 'SECONDARY', 'title': 'Participants With CML-AP/BP: Percentage of Participants With Hematologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CML-AP/BP - Total Cohort', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'CML-AP/BP - Imatinib Resistant', 'description': 'Imatinib resistant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG002', 'title': 'CML-AP/BP - Imatinib Intolerant', 'description': 'Imatinib intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'title': 'Overall hematologic response (OHR)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '39.0', 'upperLimit': '94.0'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '34.9', 'upperLimit': '96.8'}, {'value': '67', 'groupId': 'OG002', 'lowerLimit': '9.4', 'upperLimit': '99.2'}]}]}, {'title': 'Major hematologic response (MaHR)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '39.0', 'upperLimit': '94.0'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '34.9', 'upperLimit': '96.8'}, {'value': '67', 'groupId': 'OG002', 'lowerLimit': '9.4', 'upperLimit': '99.2'}]}]}, {'title': 'Complete hematologic response (CHR)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '23.4', 'upperLimit': '83.3'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '34.9', 'upperLimit': '96.8'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL). CHR=WBC \\<ULN; absolute neutrophil count (ANC) \\>1,000/mm3; platelets \\>100,000/mm3; no blasts or promyelocytes in peripheral blood; BM blasts ≤5%; \\<5% myelocytes + metamyelocytes in peripheral blood; \\<20% basophils in peripheral blood; no extramedullary involvement. NEL=(see Outcome Measure 15, below). Overall hematologic response (OHR)=best response of CHR, NEL or return to chronic phase (RTC).', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated CML-AP/BP participants'}, {'type': 'SECONDARY', 'title': 'Participants With Ph+ ALL: Percentage of Participants With Hematologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Total Cohort', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Resistant', 'description': 'Ph+ ALL subjects with resistance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG002', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Intolerant', 'description': 'Ph+ ALL subjects with intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'title': 'Overall hematologic response (OHR)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '38.6', 'upperLimit': '90.9'}, {'value': '56', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': '86.3'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '39.8', 'upperLimit': '100.0'}]}]}, {'title': 'Major hematologic response (MaHR)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '74.9'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '70.1'}, {'value': '75.5', 'groupId': 'OG002', 'lowerLimit': '19.4', 'upperLimit': '99.4'}]}]}, {'title': 'Complete hematologic response (CHR)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '45.4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '50', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '93.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL). CHR=(see Outcome Measure 14, above). NEL=WBC ≤ULN; BM blasts ≤5%; no blasts or promyelocytes in peripheral blood; \\<5% myelocytes plus metamyelocytes in peripheral blood; \\<20% peripheral blood basophils; no extramedullary involvement; and at least 1 of the following: ANC ≥500/mm3 and \\<2000/mm3 or platelets ≥20,000/mm3 and \\<100,000/mm3. Overall hematologic response (OHR)=best response of CHR, NEL or return to chronic phase (RTC).', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Ph+ ALL participants'}, {'type': 'SECONDARY', 'title': 'Time to Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Chronic Phase (CML-CP)', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG002', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '343'}, {'value': '89', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '307'}, {'value': '98.5', 'groupId': 'OG002', 'lowerLimit': '57', 'upperLimit': '140'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'CHR=all of the following criteria: WBC ≤institutional upper limit of normal(ULN); 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. Time to CHR=time from first dose of dasatinib until the first day criteria for CHR are met provided they are confirmed 28 days later and was computed only for chronic phase CML subjects whose best response is CHR. Subjects who neither progressed nor died were censored at date of last hematologic assessment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants achieving CHR'}, {'type': 'SECONDARY', 'title': 'Duration of Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Chronic Phase (CML-CP)', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG002', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '1160', 'groupId': 'OG000', 'lowerLimit': '153', 'upperLimit': '1310'}, {'value': '373', 'groupId': 'OG002', 'lowerLimit': '102', 'upperLimit': '644'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'Duration of CHR was computed only for chronic phase CML subjects whose best response is CHR. It was measured from the first day complete hematologic response criteria are met provided they are confirmed 28 days later until the date treatment is discontinued due to PD or death. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants achieving CHR. Duration of CHR in the CML AP/BP arm has not yet been reached.'}, {'type': 'SECONDARY', 'title': 'Time to Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '102'}, {'value': '59', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '151'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL; see Outcome Measures 14 and 15 for full definitions). Time to major hematologic response (MaHR)=time from first dose of dasatinib until the first day the measurement criteria for MaHR and is computed only for advanced diseases subjects whose best response is a major hematologic response. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants achieving MaHR'}, {'type': 'SECONDARY', 'title': 'Duration of Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '102.5', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '774'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'Major Hematologic Response (MaHR)=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL; see Outcome Measures 14 and 15 for full definitions). Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of MaHR was computed only for advanced diseases subjects whose best response is a MaHR and was measured from the first day MaHR criteria are met, provided they were confirmed 28 days later until the date of PD or death. Median Duration of MaHR was not yet reached in the CML-AP/BP arm.'}, {'type': 'SECONDARY', 'title': 'Time to Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '68'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'The overall hematologic response (OHR) rate is defined as the proportion of all treated subjects with a best response of major or minor hematologic response. Time to OHR = time from first dose of dasatinib until the first day measurement criteria are first met for hematologic response provided they were confirmed 28 days later. Subjects who neither progressed nor died were censored on the date of last hematologic assessment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'OHR was computed only for subjects whose best response is CHR or MaHR or Minor HR (MiHR).'}, {'type': 'SECONDARY', 'title': 'Duration of Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '104', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '774'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'The overall hematologic response (OHR) rate is defined as the proportion of all treated subjects with a best response of major or minor hematologic response. Subjects who neither progressed nor died were censored on the date of last hematologic assessment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of OHR was computed only for participants whose best response was CHR or a MaHR or MiHR \\& was measured from the first day hematologic response criteria were met, provided they were confirmed 28 days later until the date of PD or death. Median duration of OHR in the CML-AP/BP arm was not yet reached.'}, {'type': 'SECONDARY', 'title': 'Participants With Detectable Mutations of RNA (mRNA) of BCR-ABL at Baseline and at Best Achievement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Chronic Phase (CML-CP)', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG002', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Best Achievement', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter, and at discontinuation', 'description': 'Detectable BCR-ABL transcripts (b3a2, b2a2 or minor) \\>=2.0 log copy/micrograms RNA, as measured by real-time quantitative PCR (RQ-PCR) at baseline and best achievement post-dose.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants'}, {'type': 'SECONDARY', 'title': 'Status of Point Mutations of BCR-ABL at Baseline (BL) and End of Study (EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Chronic Phase (CML-CP)', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG002', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'classes': [{'title': 'Undetectable at BL → Detectable at EOS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Detectable at BL → Detectable at EOS', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Detectable at BL → Undetectable at EOS', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Detectable at BL → Not Analyzed at EOS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline and discontinuation--the study period was extended until the launch of dasatinib in Japan, January 2009.', 'description': 'Point mutations of BCR-ABL detected or undetected in the Quantitative real-time PCR polymerase chain reaction (RQ-PCR) products', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants'}, {'type': 'SECONDARY', 'title': 'Collection of Blood Samples for Pharmacokinetic Analysis of Dasatinib Twice Daily (BID) That Will Contribute to Population Pharmacokinetic Modeling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CML - Chronic Phase (CML-CP)', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG001', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'OG002', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'paramType': 'NUMBER', 'timeFrame': 'At any visit of later than Day 7, draw sample(s) at pretreatment trough (within 1 hour prior to dosing) or between 3 hours following treatment and prior to the next dose', 'description': 'Blood samples for pharmacokinetic analysis of Dasatinib BID that will contribute to population pharmacokinetic modeling were collected.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There was no individual PK analysis done for this study; analyses were integrated and evaluated as a part of population PK of this drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CML - Chronic Phase (CML-CP)', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'FG001', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'FG002', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Philadelphia chromosome positive (Ph+) ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}], 'periods': [{'title': 'Studies CA180-031 and -036 Combined', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Insufficient effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Study CA180-036 Only', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'insufficient effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'CA180-031 = NCT00337454; CA180-036 = NCT01030718', 'preAssignmentDetails': '55 participants were randomized to study CA180-031; 1 participant with chronic myelogenous leukemia-chronic phase (CML-CP) was withdrawn prior to dosing due to thrombocytopenia. 54 subjects were treated; 44 subjects finished the study period of CA180-031 and transferred CA180-036. Analyses were done on the population enrolled into CA180-031 study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CML - Chronic Phase (CML-CP)', 'description': 'Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'BG001', 'title': 'CML - Accelerated Phase and Blast Phase (CML-AP/BP)', 'description': 'Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'BG002', 'title': 'Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)', 'description': 'Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '68'}, {'value': '57.0', 'groupId': 'BG001', 'lowerLimit': '31', 'upperLimit': '73'}, {'value': '64.0', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '70'}, {'value': '55.5', 'groupId': 'BG003', 'lowerLimit': '27', 'upperLimit': '73'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Eastern Oncology Cooperative Group Performance Status', 'classes': [{'title': 'Status = 0', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}, {'title': 'Status = 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Status = 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Status = 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Status = 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Status = 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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': 'Resistant', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': 'Intolerant', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Resistance to Imatinib=Previously been treated with imatinib at a dose of ≥ 400 mg/day AND developed progressive disease while receiving imatinib at that dose. Intolerance to Imatinib=A subject is defined as being intolerant to imatinib if he or she had 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'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '64.05', 'groupId': 'BG000', 'lowerLimit': '44.0', 'upperLimit': '86.5'}, {'value': '58.00', 'groupId': 'BG001', 'lowerLimit': '43.6', 'upperLimit': '76.6'}, {'value': '53.20', 'groupId': 'BG002', 'lowerLimit': '37.0', 'upperLimit': '77.8'}, {'value': '60.55', 'groupId': 'BG003', 'lowerLimit': '37.0', 'upperLimit': '86.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '163.65', 'groupId': 'BG000', 'lowerLimit': '147.0', 'upperLimit': '180.3'}, {'value': '161.00', 'groupId': 'BG001', 'lowerLimit': '145.7', 'upperLimit': '174.5'}, {'value': '164.50', 'groupId': 'BG002', 'lowerLimit': '151.7', 'upperLimit': '171.7'}, {'value': '163.25', 'groupId': 'BG003', 'lowerLimit': '145.7', 'upperLimit': '180.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-15', 'studyFirstSubmitDate': '2009-12-10', 'resultsFirstSubmitDate': '2010-07-26', 'studyFirstSubmitQcDate': '2009-12-10', 'lastUpdatePostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-15', 'studyFirstPostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation', 'timeFrame': 'baseline; every 4 weeks (if on study < 6 months, including CA180-031(NCT00337454); every 12 weeks (if on study >=6 months and <=2 years); every 24 weeks (if on study >2 years); at discontinuation', '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 development of drug dependency or drug abuse, is an important medical event.'}], 'secondaryOutcomes': [{'measure': 'Participants With Chronic Phase CML (CML-CP): Percentage of Participants With Cytogenetic Response', 'timeFrame': 'At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)', 'description': 'Cytogenetic responses (CyR) are based on the percentage of 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), plus Partial Cytogenetic Response (PCyR; 1 - 35 Philadelphia positive \\[Ph+\\] Cells in Metaphase in BM).'}, {'measure': 'Participants With CML-Accelerated or Blast Phase (AP/BP): Percentage of Participants With Cytogenetic Response', 'timeFrame': 'At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter', 'description': 'Cytogenetic responses (CyR) are based on the percentage of 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), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).'}, {'measure': 'Participants With Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL): Percentage of Participants With Cytogenetic Response', 'timeFrame': 'At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter', 'description': 'Cytogenetic responses (CyR) are based on the percentage of 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), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).'}, {'measure': 'Participants With CML-CP: Time to Complete Cytogenetic Response (CCyR)', 'timeFrame': 'At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454),', 'description': 'Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Time to complete CCyR is defined as the time from first dose of dasatinib until measurement criteria are first met for CCyR, and is computed only for subjects whose best response is CCyR.'}, {'measure': 'Participants With CML-AP/BP and Ph+ ALL: Time to Complete Cytogenetic Response (CCyR)', 'timeFrame': 'At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter', 'description': 'Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Time to complete CCyR is defined as the time from first dose of dasatinib until measurement criteria are first met for CCyR, and is computed only for subjects whose best response is CCyR.'}, {'measure': 'Participants With CML-CP: Duration of Complete Cytogenetic Response (CCyR)', 'timeFrame': 'At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)', 'description': 'Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Duration of CCyR was measured from the time measurement criteria are first met for CCyR until the first date of progressed disease (PD) or death. Subjects who neither relapsed nor died will be censored on the date of their last assessment.'}, {'measure': 'Participants With CML-AP/BP and Ph+ALL: Duration of Complete Cytogenetic Response (CCyR)', 'timeFrame': 'At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter', 'description': 'Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Duration of CCyR was measured from the time measurement criteria are first met for CCyR until the first date of PD or death. Subjects who neither relapsed nor died will be censored on the date of their last assessment.'}, {'measure': 'Participants With CML-CP: Time to Major Cytogenetic Response (MCyR)', 'timeFrame': 'At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)', 'description': 'Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Time to MCyR was defined as the time from first dose of dasatinib until measurement criteria were first met for CCyR or PCyR (whichever status is recorded first).'}, {'measure': 'Participants With CML-AP/BP and Ph+ALL: Time to Major Cytogenetic Response (MCyR)', 'timeFrame': 'At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter', 'description': 'Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Time to MCyR was defined as the time from first dose of dasatinib until measurement criteria were first met for CCyR or PCyR (whichever status is recorded first).'}, {'measure': 'Participants With CML-CP: Duration of Major Cytogenetic Response (MCyR)', 'timeFrame': 'At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)', 'description': 'Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Duration of MCyR was measured from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the first date of progressive disease (PD) or death. Subjects who neither relapsed nor died were censored on the date of their last assessment.'}, {'measure': 'Participants With CML-AP/BP and Ph+ ALL: Duration of Major Cytogenetic Response (MCyR)', 'timeFrame': 'At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter', 'description': 'Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Duration of MCyR was measured from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the first date of progressive disease (PD) or death. Subjects who neither relapsed nor died were censored on the date of their last assessment.'}, {'measure': 'Participants With CML-CP: Percentage of Participants With Complete Hematologic Response (CHR)', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454), every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'CHR=all of the following criteria: white blood cell count (WBC) ≤institutional upper limit of normal(ULN); 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.'}, {'measure': 'Participants With CML-AP/BP: Percentage of Participants With Hematologic Response', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL). CHR=WBC \\<ULN; absolute neutrophil count (ANC) \\>1,000/mm3; platelets \\>100,000/mm3; no blasts or promyelocytes in peripheral blood; BM blasts ≤5%; \\<5% myelocytes + metamyelocytes in peripheral blood; \\<20% basophils in peripheral blood; no extramedullary involvement. NEL=(see Outcome Measure 15, below). Overall hematologic response (OHR)=best response of CHR, NEL or return to chronic phase (RTC).'}, {'measure': 'Participants With Ph+ ALL: Percentage of Participants With Hematologic Response', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL). CHR=(see Outcome Measure 14, above). NEL=WBC ≤ULN; BM blasts ≤5%; no blasts or promyelocytes in peripheral blood; \\<5% myelocytes plus metamyelocytes in peripheral blood; \\<20% peripheral blood basophils; no extramedullary involvement; and at least 1 of the following: ANC ≥500/mm3 and \\<2000/mm3 or platelets ≥20,000/mm3 and \\<100,000/mm3. Overall hematologic response (OHR)=best response of CHR, NEL or return to chronic phase (RTC).'}, {'measure': 'Time to Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'CHR=all of the following criteria: WBC ≤institutional upper limit of normal(ULN); 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. Time to CHR=time from first dose of dasatinib until the first day criteria for CHR are met provided they are confirmed 28 days later and was computed only for chronic phase CML subjects whose best response is CHR. Subjects who neither progressed nor died were censored at date of last hematologic assessment.'}, {'measure': 'Duration of Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'Duration of CHR was computed only for chronic phase CML subjects whose best response is CHR. It was measured from the first day complete hematologic response criteria are met provided they are confirmed 28 days later until the date treatment is discontinued due to PD or death. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.'}, {'measure': 'Time to Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL; see Outcome Measures 14 and 15 for full definitions). Time to major hematologic response (MaHR)=time from first dose of dasatinib until the first day the measurement criteria for MaHR and is computed only for advanced diseases subjects whose best response is a major hematologic response. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.'}, {'measure': 'Duration of Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'Major Hematologic Response (MaHR)=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL; see Outcome Measures 14 and 15 for full definitions). Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.'}, {'measure': 'Time to Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'The overall hematologic response (OHR) rate is defined as the proportion of all treated subjects with a best response of major or minor hematologic response. Time to OHR = time from first dose of dasatinib until the first day measurement criteria are first met for hematologic response provided they were confirmed 28 days later. Subjects who neither progressed nor died were censored on the date of last hematologic assessment.'}, {'measure': 'Duration of Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL', 'timeFrame': 'baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation', 'description': 'The overall hematologic response (OHR) rate is defined as the proportion of all treated subjects with a best response of major or minor hematologic response. Subjects who neither progressed nor died were censored on the date of last hematologic assessment.'}, {'measure': 'Participants With Detectable Mutations of RNA (mRNA) of BCR-ABL at Baseline and at Best Achievement', 'timeFrame': 'At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter, and at discontinuation', 'description': 'Detectable BCR-ABL transcripts (b3a2, b2a2 or minor) \\>=2.0 log copy/micrograms RNA, as measured by real-time quantitative PCR (RQ-PCR) at baseline and best achievement post-dose.'}, {'measure': 'Status of Point Mutations of BCR-ABL at Baseline (BL) and End of Study (EOS)', 'timeFrame': 'At baseline and discontinuation--the study period was extended until the launch of dasatinib in Japan, January 2009.', 'description': 'Point mutations of BCR-ABL detected or undetected in the Quantitative real-time PCR polymerase chain reaction (RQ-PCR) products'}, {'measure': 'Collection of Blood Samples for Pharmacokinetic Analysis of Dasatinib Twice Daily (BID) That Will Contribute to Population Pharmacokinetic Modeling', 'timeFrame': 'At any visit of later than Day 7, draw sample(s) at pretreatment trough (within 1 hour prior to dosing) or between 3 hours following treatment and prior to the next dose', 'description': 'Blood samples for pharmacokinetic analysis of Dasatinib BID that will contribute to population pharmacokinetic modeling were collected.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Myelogenous Leukemia', 'Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant or intolerant to treatment and will continue study drug after completing the previous Phase I/II study (CA180031/NCT00337454)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who were eligible and completed the previous Phase I and II study (CA180031/NCT00337454) and for whom the principal investigator has deemed that continuation of study drug is in the best interest of the subject\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Subjects who are eligible and willing to undergo transplantation at pre-study\n* Non-hematologic intolerance to Dasatinib (BMS-354825) in the previous Phase I and II study (CA180031/NCT00337454)'}, 'identificationModule': {'nctId': 'NCT01030718', 'briefTitle': 'Rollover Study of BMS-354825 in Patients With CML and Ph+ALL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Study to Document the Long-Term Safety and Efficacy of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Previous Treatment and Have Completed the Previous Phase I/II Protocol (CA180-031/NCT00337454)', 'orgStudyIdInfo': {'id': 'CA180-036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dasatinib (CML-CP)', 'description': 'CML - Chronic Phase', 'interventionNames': ['Drug: dasatinib']}, {'type': 'EXPERIMENTAL', 'label': 'dasatinib (CML-AP/BP)', 'description': 'CML - Accelerated Phase and Blast Phase', 'interventionNames': ['Drug: dasatinib']}, {'type': 'EXPERIMENTAL', 'label': 'dasatinib (Ph+ ALL)', 'description': 'Ph+ Acute Lymphoblastic Leukemia', 'interventionNames': ['Drug: dasatinib']}], 'interventions': [{'name': 'dasatinib', 'type': 'DRUG', 'otherNames': ['Sprycel', 'BMS-354825'], 'description': 'Tablet, Oral, (50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID', 'armGroupLabels': ['dasatinib (CML-AP/BP)', 'dasatinib (CML-CP)', 'dasatinib (Ph+ ALL)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}