Viewing Study NCT00101660

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Ignite Creation Date: 2025-12-25 @ 2:03 AM
Ignite Modification Date: 2026-03-09 @ 4:05 AM
Study NCT ID: NCT00101660
Status: COMPLETED
Last Update Posted: 2012-03-02
First Post: 2005-01-12
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China', 'Hungary', 'Philippines', 'Poland', 'Russia', 'Taiwan']}, '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': 'Intolerant', 'otherNumAtRisk': 99, 'otherNumAffected': 96, 'seriousNumAtRisk': 99, 'seriousNumAffected': 48}, {'id': 'EG001', 'title': 'Resistant', 'otherNumAtRisk': 288, 'otherNumAffected': 287, 'seriousNumAtRisk': 288, 'seriousNumAffected': 146}], 'otherEvents': [{'term': 'EYELID OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VISION BLURRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'WEIGHT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 30}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PERICARDIAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'FLUSHING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HOT FLUSH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 19}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 33}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 20}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 128}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 56}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 108}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'COLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 64}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 153}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'TOOTHACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'FLATULENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HAEMORRHOIDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 47}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MOUTH ULCERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ABDOMINAL DISTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ORAL HERPES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 53}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ANOREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 52}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 52}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 67}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ACNE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 103}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 36}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'URTICARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SKIN LESION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NIGHT SWEATS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 34}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPERHIDROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PERIORBITAL OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DERMATITIS ACNEIFORM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 21}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 49}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 53}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 48}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NECK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 86}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 58}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MUSCULOSKELETAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 110}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 128}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'WHEEZING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DYSPHONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'RHINORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 90}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DYSPNOEA EXERTIONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PHARYNGOLARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 42}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG001', 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'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SKIN NECROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ENDOMETRIOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'UTERINE HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SKIN LACERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'JOINT DISLOCATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SUBDURAL HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ACCIDENTAL OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'FACIAL BONES FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PROCEDURAL COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'TENOSYNOVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'RHABDOMYOLYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MUSCULOSKELETAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'STRIDOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CHYLOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PNEUMONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BRONCHOSPASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LUNG DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PLEURAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 32}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LUNG INFILTRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DYSPNOEA EXERTIONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BRONCHIAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NASAL SEPTUM DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PULMONARY HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INTERSTITIAL LUNG DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MALAISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ADVERSE EVENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'METASTASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SKIN CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ADENOCARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LEIOMYOSARCOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MYELODYSPLASTIC SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CHRONIC MYELOID LEUKAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CHRONIC LYMPHOCYTIC LEUKAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SQUAMOUS CELL CARCINOMA OF SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'METASTATIC SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BLAST CRISIS IN MYELOGENOUS LEUKAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib, 70 mg, Twice Daily (BID)', 'description': 'Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.'}], 'classes': [{'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All imatinib-resistant participants who received treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Imatinib-intolerant Participants With MCyR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dastinib, 70 mg, BID', 'description': 'Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 2 years', 'description': 'Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All imatinib-intolerant participants who received treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatanib, 70 mg BID', 'description': 'Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.'}], 'classes': [{'title': 'Imatinib-intolerant group: 12 months (n=81)', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-intolerant group: 24 months (n=81)', 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-resistant group: 12 months (n=159)', 'categories': [{'measurements': [{'value': '93.7', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-resistant group: 24 months (n=159)', 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 and 24 Months', 'description': 'Based on the Kaplan-Meier estimate of the duration of response. Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases and Partial Cytogenetic Response (PCyR) - 1% to 35% Ph+ metaphases.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population is limited to responders (those who acheived MCyR) who were also assessed for duration of MCyR.'}, {'type': 'SECONDARY', 'title': 'Median Time From First Dosing Date to Date of MCyR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib, 70 mg BID', 'description': 'Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.'}], 'classes': [{'title': 'Imatinib-intolerant', 'categories': [{'measurements': [{'value': '2.79', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '16.39'}]}]}, {'title': 'Imatinib-resistant', 'categories': [{'measurements': [{'value': '2.92', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '22.37'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (within 4 weeks of Day 1) and every 12 weeks', 'description': 'MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Population is limited to responders (those who acheived MCyR) only'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complete Hematologic Response (CHR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib, 70 mg BID', 'description': 'Dasatinib, 70 mg twice BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.'}], 'classes': [{'title': 'Imatinib-intolerant (n=99)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-resistant (n=288)', 'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study', 'description': 'CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \\<450,000/mm\\^3; no blasts or promyelocytes in peripheral blood; \\<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib,70 mg BID', 'description': 'Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.'}], 'classes': [{'title': 'Imatinib-intolerant: 12 months (n=93)', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-intolerant: 24 months (n=93)', 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-resistant: 12 months (n=259)', 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-resistant: 24 months (n=259)', 'categories': [{'measurements': [{'value': '78.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 and 24 months', 'description': 'Based on the Kaplan-Meier estimate of the duration of response. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \\< 450,000/mm\\^3; no blasts or promyelocytes in peripheral blood; \\<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population limited to responders (those achieving CHR) only'}, {'type': 'SECONDARY', 'title': 'Median Time From First Dosing Until CHR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib, 70 mg BID', 'description': 'Dasatinib, 70 mg twice BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.'}], 'classes': [{'title': 'Imatinib-intolerant (n=93)', 'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000', 'lowerLimit': '0.46', 'upperLimit': '3.78'}]}]}, {'title': 'Imatinib-resistant (n=259)', 'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000', 'lowerLimit': '0.46', 'upperLimit': '12.39'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study', 'description': 'CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \\<450,000/mm\\^3; no blasts or promyelocytes in peripheral blood; \\<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Population limited to responders (those achieving CHR) only'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Molecular Response (MMR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib, 70 mg BID', 'description': 'Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.'}], 'classes': [{'title': 'Imatinib-intolerant (n=99)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-resistant (n=288)', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 2 years', 'description': 'MMR is defined as ≤3 log reduction in BCR-ABL levels from the standardized baseline value of BCR-ABL:Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL:Control gene ratio by the lab-specific conversion factor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received treatment.'}, {'type': 'SECONDARY', 'title': 'Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib,70 mg BID', 'description': 'Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.'}], 'classes': [{'title': 'Imatinib-intolerant: Total FACT-G (n=80)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-intolerant: PWB (n=80)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-intolerant: SWB (n=80)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-intolerant: EWB (n=80)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-intolerant: FWB (n=80)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-resistant: Total FACT-G (n=241)', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-resistant: PWB (n=241)', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-resistant: SWB (n=241)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-resistant: EWB (n=241)', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}, {'title': 'Imatinib-resistant: FWB (n=241)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria.', 'description': 'Health-related quality of life as measured by FACT-G, which comprises 27 questions in 4 domains: PWB, SWB, EWB, FWB. Total FACT-G score=summation of the 4 subscale scores and ranges from 0 to 108. Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, \\& FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinical important change. Baseline FACT-G measurements can be found in Baseline Characteristics.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with assessments at baseline and timepoint'}, {'type': 'SECONDARY', 'title': 'Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib,70 mg BID', 'description': 'Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.'}], 'classes': [{'title': 'Drug-related AEs', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': 'Death within 30 days of last dose', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'On-study AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3-4 thrombocytopenia', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3-4 neutropenia', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Any AE', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Continuously, from baseline through 2 years', 'description': 'AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All imitanib-intolerant participants who received treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib,70 mg BID', 'description': 'Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.\n\na'}], 'classes': [{'title': 'Drug-related AEs', 'categories': [{'measurements': [{'value': '281', 'groupId': 'OG000'}]}]}, {'title': 'Death within 30 days of last dose', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'On-study AEs leading to Discontinuation', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3-4 thrombocytopenia', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3-4 neutropenia', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}, {'title': 'Any AE', 'categories': [{'measurements': [{'value': '288', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Continuously, from baseline through 2 years', 'description': 'AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All imitanib-resistant participants who received treatment.'}, {'type': 'SECONDARY', 'title': 'Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib', 'description': 'Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8 of study; pretreatment through sample between 30 minutes and 3 hours following treatment, a sample between 5 hours and 8 hours following treatment and a sample at 12 hours, prior to the next dose.', 'description': 'Blood samples were collected for PK to be included in separate population PK analyses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No study-specific PK analyses were planned for this report.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Imatinib-intolerant', 'description': 'Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.'}, {'id': 'FG001', 'title': 'Imatinib-resistant', 'description': 'Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm\\^3; an absolute increase in WBC by more than 50,000/mm\\^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '288'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '288'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Imatinib-intolerant', 'description': 'Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.'}, {'id': 'BG001', 'title': 'Imatinib-resistant', 'description': 'Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm\\^3; an absolute increase in WBC by more than 50,000/mm\\^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.6', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '55.7', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '55.4', 'spread': '13.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Between 21 and 45 years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'Between 46 and 65 years', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}]}, {'title': 'Between 66 and 75 years', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': '> 75 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Performance Status - Eastern Cooperative Oncology Group Scale (ECOG) Score', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'ECOG scale is a 6-item scale used to assess disease progression, daily functioning, and appropriate treatment and prognosis. Scale 1-5, with 0=fully active, able to carry on all predisease performance without restriction, 1=physically strenous activity restricted, 2=capable of self-care, unable to work, 3=capable of only limited self-care, bed/chair confined for \\>50% of time, 4=completely disbled, bed/chair confined, and 5=death', 'unitOfMeasure': 'Participants'}, {'title': 'Functional Assessment of Cancer Therapy-General (FACT-G)', 'classes': [{'title': 'Total FACT-G', 'categories': [{'measurements': [{'value': '81.1', 'spread': '14.4', 'groupId': 'BG000'}, {'value': '82.4', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '82.1', 'spread': '13.4', 'groupId': 'BG002'}]}]}, {'title': 'PWB', 'categories': [{'measurements': [{'value': '22.0', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '21.6', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '21.7', 'spread': '5.2', 'groupId': 'BG002'}]}]}, {'title': 'SWB', 'categories': [{'measurements': [{'value': '23.0', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '23.0', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '23.0', 'spread': '4.4', 'groupId': 'BG002'}]}]}, {'title': 'EWB', 'categories': [{'measurements': [{'value': '17.3', 'spread': '4.0', 'groupId': 'BG000'}, {'value': '18.4', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '18.1', 'spread': '3.8', 'groupId': 'BG002'}]}]}, {'title': 'FWB', 'categories': [{'measurements': [{'value': '18.7', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '19.6', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '19.4', 'spread': '5.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'FACT-G=27 questions in 4 domains: physical, social/family, emotional, functional well-being (PWB, SWB, EWB, FWB). Total score=0 to 108; higher score=better health-related quality of life. 13 participants in imatinib-intolerant group had baseline measurements; 161 participants in imatinib-resistant group had baseline measurements for all 4 domains/79 had baseline measurements for total scores. Imatinib-intolerant participants assessed at baseline: n=78 for Total, EWB, FWB; n=80 for PWB, SWB. Imatinib-resistant participants assessed at baseline: n=234, Total; n=238, PWB, FWB; n=237, SWB, EWB.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 387}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-29', 'studyFirstSubmitDate': '2005-01-12', 'resultsFirstSubmitDate': '2009-12-22', 'studyFirstSubmitQcDate': '2005-01-12', 'lastUpdatePostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-09', 'studyFirstPostDateStruct': {'date': '2005-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)', 'timeFrame': '2 years', 'description': 'Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.'}], 'secondaryOutcomes': [{'measure': 'Number of Imatinib-intolerant Participants With MCyR', 'timeFrame': 'Baseline to 2 years', 'description': 'Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.'}, {'measure': 'Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months', 'timeFrame': '12 and 24 Months', 'description': 'Based on the Kaplan-Meier estimate of the duration of response. Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases and Partial Cytogenetic Response (PCyR) - 1% to 35% Ph+ metaphases.'}, {'measure': 'Median Time From First Dosing Date to Date of MCyR', 'timeFrame': 'Baseline (within 4 weeks of Day 1) and every 12 weeks', 'description': 'MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.'}, {'measure': 'Number of Participants With Complete Hematologic Response (CHR)', 'timeFrame': 'Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study', 'description': 'CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \\<450,000/mm\\^3; no blasts or promyelocytes in peripheral blood; \\<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.'}, {'measure': 'Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months', 'timeFrame': '12 and 24 months', 'description': 'Based on the Kaplan-Meier estimate of the duration of response. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \\< 450,000/mm\\^3; no blasts or promyelocytes in peripheral blood; \\<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.'}, {'measure': 'Median Time From First Dosing Until CHR', 'timeFrame': 'Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study', 'description': 'CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \\<450,000/mm\\^3; no blasts or promyelocytes in peripheral blood; \\<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.'}, {'measure': 'Number of Participants With Major Molecular Response (MMR)', 'timeFrame': 'Baseline to 2 years', 'description': 'MMR is defined as ≤3 log reduction in BCR-ABL levels from the standardized baseline value of BCR-ABL:Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL:Control gene ratio by the lab-specific conversion factor.'}, {'measure': 'Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores', 'timeFrame': 'Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria.', 'description': 'Health-related quality of life as measured by FACT-G, which comprises 27 questions in 4 domains: PWB, SWB, EWB, FWB. Total FACT-G score=summation of the 4 subscale scores and ranges from 0 to 108. Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, \\& FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinical important change. Baseline FACT-G measurements can be found in Baseline Characteristics.'}, {'measure': 'Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE', 'timeFrame': 'Continuously, from baseline through 2 years', 'description': 'AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)'}, {'measure': 'Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE', 'timeFrame': 'Continuously, from baseline through 2 years', 'description': 'AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)'}, {'measure': 'Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib', 'timeFrame': 'Day 8 of study; pretreatment through sample between 30 minutes and 3 hours following treatment, a sample between 5 hours and 8 hours following treatment and a sample at 12 hours, prior to the next dose.', 'description': 'Blood samples were collected for PK to be included in separate population PK analyses.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic phase Philadelphia chromosome chronic myeloid leukemia (Ph+CML)'], 'conditions': ['Chronic Myeloid Leukemia', 'Philadelphia-Positive Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '17138817', 'type': 'BACKGROUND', 'citation': 'Hochhaus A, Kantarjian HM, Baccarani M, Lipton JH, Apperley JF, Druker BJ, Facon T, Goldberg SL, Cervantes F, Niederwieser D, Silver RT, Stone RM, Hughes TP, Muller MC, Ezzeddine R, Countouriotis AM, Shah NP. Dasatinib induces notable hematologic and cytogenetic responses in chronic-phase chronic myeloid leukemia after failure of imatinib therapy. Blood. 2007 Mar 15;109(6):2303-9. doi: 10.1182/blood-2006-09-047266. Epub 2006 Nov 30.'}, {'pmid': '19779040', 'type': 'BACKGROUND', 'citation': 'Muller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. doi: 10.1182/blood-2009-04-214221. Epub 2009 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is assess the effects of the investigational drug dasatinib on participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and who are either resistant to or intolerant of imatinib. Other purposes of the study are to identify any side effects the drug may produce and to study the level of dasatanib in the blood and assess the efficacy of dasatanib in the treatment of leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 18 years and older.\n* Chronic myeloid leukemia (CML)\n* Previous treatment with imatinib at a dose of \\>600 mg/day AND the development of progressive disease while receiving imatinib at that dose, OR\n* CML with resistance to imatinib at a dose less than or equal to 600 mg/day with genetic mutation in the BCR-ABL gene that is associated with a high level of resistance to imatinib, OR\n* Intolerance to imatinib at any dose\n* Adequate organ function\n* Women who are able to bear children must have a negative serum or urine pregnancy test. Adequate methods of contraception must be used throughout the study to avoid pregnancy for the entire interval of at least 1 month before and 3 months after completion of the study medication.\n\nExclusion Criteria:\n\n* Woman who are pregnant or breastfeeding\n* Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above\n* Previous diagnosis of accelerated phase or blast crisis CML.\n* Participants who are eligible and willing to undergo transplantation during the screening period\n* Uncontrolled or significant cardiovascular disease\n* Use of imatinib within 7 days.\n* Use of interferon or cytarabine within 14 days\n* Use of a targeted small-molecule anticancer agent within 14 days\n* Use of certain medication that carry a known side effect risk of Torsade de Pointes - Certain medications that irreversibly inhibit platelet function or anticoagulants\n* Prior therapy with dasatinib.'}, 'identificationModule': {'nctId': 'NCT00101660', 'briefTitle': 'Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib', 'nctIdAliases': ['NCT00112801'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase II Study to Determine the Activity of BMS-354825 in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who Are Intolerant of Imatinib', 'orgStudyIdInfo': {'id': 'CA180-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dasatinib, 70 mg twice daily (BID)', 'description': 'Dasatanib, 70 mg twice daily (BID), with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.', 'interventionNames': ['Drug: Dasatinib']}], 'interventions': [{'name': 'Dasatinib', 'type': 'DRUG', 'description': 'Tablets; oral; 70 mg BID, depending on response', 'armGroupLabels': ['Dasatinib, 70 mg twice daily (BID)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'city': 'Vallejo', 'state': 'California', 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'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}