Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-25 @ 4:18 PM
Study NCT ID:
NCT02130557
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2014-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D010677', 'term': 'Philadelphia Chromosome'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D014178', 'term': 'Translocation, Genetic'}, {'id': 'D010335', 'term': 'Pathologic Processes'}], 'ancestors': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002869', 'term': 'Chromosome Aberrations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C471992', 'term': 'bosutinib'}, {'id': 'D000068877', 'term': 'Imatinib Mesylate'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of drug up to 28 days after last dose (up to Month 60)', 'description': 'All-cause mortality: The total number of deaths occurred during study (from randomization and up to month 60) are reported for all randomized participants, not only for treated participants, and included deaths which occurred after 28 days post last study drug dose. Serious AEs and other AEs: Analysis performed on safety population. The safety population included all participants, regardless of Philadelphia chromosome or transcript status, who received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.', 'otherNumAtRisk': 268, 'deathsNumAtRisk': 268, 'otherNumAffected': 264, 'seriousNumAtRisk': 268, 'deathsNumAffected': 14, 'seriousNumAffected': 98}, {'id': 'EG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.', 'otherNumAtRisk': 265, 'deathsNumAtRisk': 268, 'otherNumAffected': 260, 'seriousNumAtRisk': 265, 'deathsNumAffected': 14, 'seriousNumAffected': 68}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 53}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 59}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 61}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 34}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 44}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 24}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 18}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 16}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 18}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 201}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 106}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 112}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 54}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 30}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 49}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 81}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 48}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 41}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Prostatic dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pulmonary toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lichen planus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pregnancy of partner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Major Molecular Response (MMR) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'groupId': 'OG000', 'lowerLimit': '40.9', 'upperLimit': '53.4'}, {'value': '36.9', 'groupId': 'OG001', 'lowerLimit': '30.8', 'upperLimit': '43.0'}]}]}], 'analyses': [{'pValue': '0.0100', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.547', 'ciLowerLimit': '1.072', 'ciUpperLimit': '2.233', 'pValueComment': '1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.025.', 'estimateComment': '95% Confidence Interval (CI) for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.', 'groupDescription': "A total sample size of 500 Ph+ participants is required for the study to provide \\>= 90% power to detect at least 15% difference (assuming 25% in the imatinib vs 40% in the bosutinib arm) in the MMR rates at 12 months (48 weeks) with a 1-sided alpha of 2.5%, and 2 interim futility analyses at 33% and 66% of patients with adequate follow-up with early stopping for futility only (non-binding, O'Brien-Fleming analog beta spending function).", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'MMR was defined as a ratio of breakpoint cluster region to abelson (BCR-ABL/ABL) less than or equal to (\\<=) 0.1 percent (%) on the international scale (IS) (greater than or equal to \\[\\>=\\] 3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts \\[\\>=3000 ABL required\\]) by quantitative reverse transcriptase polymerase chain reaction (RT-qPCR). The percentage of participants with MMR at Month 12 are reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population included all randomized participants with Philadelphia chromosome positive (Ph+) CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies greater than (\\>) 0 with study drug assignment designated according to initial randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Major Molecular Response (MMR) Up to Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000', 'lowerLimit': '54.9', 'upperLimit': '67.1'}, {'value': '52.7', 'groupId': 'OG001', 'lowerLimit': '46.4', 'upperLimit': '59.0'}]}]}], 'analyses': [{'pValue': '0.0303', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.418', 'ciLowerLimit': '0.986', 'ciUpperLimit': '2.037', 'pValueComment': '1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.0125.', 'estimateComment': '95% CI for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.', 'groupDescription': "If the primary analysis was significant, each member of the short-term family (CCyR by Month 12, MMR by Month 18) was tested via Bonferroni's procedure at the 1-sided level of 0.0125.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 18', 'description': 'MMR was defined as a ratio of BCR-ABL/ABL \\<=0.1% on the international scale (\\>=3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts \\[\\>=3000 ABL required\\]) by quantitative RT-qPCR. The percentage of participants with MMR for up to Month 18 are reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \\>0 with study drug assignment designated according to initial randomization.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000', 'lowerLimit': '86.8', 'upperLimit': '95.4'}, {'value': '92.0', 'groupId': 'OG001', 'lowerLimit': '85.9', 'upperLimit': '95.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.49', 'ciUpperLimit': '2.44', 'estimateComment': 'Hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.', 'groupDescription': 'The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 48', 'description': 'The Kaplan-Meier curve was generated based on the first date of MMR until the date of the confirmed loss of MMR or censoring, objectively documented, for responders only. Confirmed loss of MMR was BCR-ABL/ABL IS ratio \\>0.1% in association with a \\>=5-fold increase in BCR-ABL/ABL IS ratio from the lowest value achieved up to that time-point confirmed by a second assessment at least 28 days later. Treatment discontinuation due to suboptimal response/treatment failure, progressive disease (PD) or death due to PD within 28 days of last dose were considered confirmed loss of MMR. PD was defined as disease progression to accelerated phase (AP) or blast phase (BP) CML.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \\>0 with study drug assignment designated according to initial randomization and who achieved MMR (responders). Here, "Overall number of Participants Analyzed (N)" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Cytogenetic Response (CCyR) Up to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.2', 'groupId': 'OG000', 'lowerLimit': '72.0', 'upperLimit': '82.5'}, {'value': '66.4', 'groupId': 'OG001', 'lowerLimit': '60.4', 'upperLimit': '72.4'}]}]}], 'analyses': [{'pValue': '0.0037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.740', 'ciLowerLimit': '1.160', 'ciUpperLimit': '2.610', 'pValueComment': '1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.0125.', 'estimateComment': '95% CI for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.', 'groupDescription': "If the primary analysis was significant, each member of the short-term family (CCyR by Month 12, MMR by Month 18) was tested via Bonferroni's procedure at the 1-sided level of 0.0125.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 12', 'description': 'Complete Cytogenetic Response (CCyR) was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. The percentage of participants with CCyR for up to Month 12 are reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \\>0 with study drug assignment designated according to initial randomization.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000', 'lowerLimit': '93.9', 'upperLimit': '98.9'}, {'value': '93.7', 'groupId': 'OG001', 'lowerLimit': '88.9', 'upperLimit': '96.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '0.14', 'ciUpperLimit': '1.13', 'estimateComment': 'Hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.', 'groupDescription': 'The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 48', 'description': 'The Kaplan-Meier curve was generated based on the first date of CCyR until the date of the confirmed loss of CCyR or censoring, objectively documented, for responders only. Confirmed loss of CCyR was the presence of at least one Ph+ metaphase confirmed by a second assessment at least 28 days later. Treatment discontinuation due to suboptimal response/treatment failure, PD or death due to PD within 28 days of last dose were considered confirmed loss of CCyR. PD was defined as disease progression to AP or BP CML.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \\>0 with study drug assignment designated according to initial randomization and who achieved CCyR (responders). Here, "N" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Event Free Survival (EFS) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '10.5'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '14.6'}]}]}], 'analyses': [{'pValue': '0.0749', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.17', 'pValueComment': "1-sided p-value based on Gray's test for comparing cumulative incidence function between treatment arms stratified by sokal risk group (low, intermediate, high) and region (1-3). Statistical significance threshold: 1-sided 0.0125.", 'estimateComment': 'The hazard ratio (95% CIs) are based on the proportional subdistribution hazards model stratified by Sokal risk group and region.', 'groupDescription': "If each member of the short-term family (CCyR by Month 12, MMR by Month 18) was significant, EFS and OS were tested sequentially via the Holm's testing procedure at the 1-sided family wise level of 0.025. If one member of the short-term family was significant, EFS and OS were tested sequentially at 1-sided 0.0125.", 'statisticalMethod': "Gray's test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 60', 'description': 'EFS was defined as time from randomization to death due to any cause, transformation to AP or BP at any time, confirmed loss of complete hematologic response (CHR), confirmed loss of CCyR or censoring. Loss of CHR was defined as a hematologic assessment of non-CHR (chronic phase, AP, or BP) confirmed by 2 assessments at least 4 weeks apart. Loss of CHR was defined as appearance of any of the following: WBC count that rises to \\>20.0\\*10\\^9/L, platelet count rises to \\>=600\\*10\\^9/L, appearance of palpable spleen or other extramedullary involvement proven by biopsy, appearance of 5% myelocytes in peripheral blood, appearance of blasts or promyelocytes in peripheral blood. Loss of CCyR was defined as at least 1 Ph+ metaphase from analysis of \\<100 metaphases confirmed by follow up cytogenetic analysis after 1 month. Cumulative incidence of EFS was defined as percentage of participants with EFS event at Month 60 and was adjusted for competing risk of treatment discontinuation without event.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \\>0 with study drug assignment designated according to initial randomization.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '91.1', 'upperLimit': '97.0'}, {'value': '94.0', 'groupId': 'OG001', 'lowerLimit': '90.1', 'upperLimit': '96.4'}]}]}], 'analyses': [{'pValue': '0.2827', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.37', 'ciUpperLimit': '1.73', 'pValueComment': '1-sided p-value based on log-rank test for comparing survival curves between treatment arms stratified by sokal risk group and region. OS was not tested as EFS was not significant.', 'estimateComment': 'The hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.', 'groupDescription': "If each member of the short-term family (CCyR by Month 12, MMR by Month 18) was significant, EFS and OS were tested sequentially via the Holm's testing procedure at the 1-sided family wise level of 0.025. If one member of the short-term family was significant, EFS and OS were tested sequentially at 1-sided 0.0125.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 60', 'description': 'OS was defined as the time (in months) from randomization to the occurrence of death due to any cause or censoring. Kaplan-meier analysis was used for determination of OS. Percentage of participants who were alive were estimated in this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \\>0 with study drug assignment designated according to initial randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Summary of Trough Plasma Concentration by Complete Cytogenetic Response (CCyR) of Bosutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.282', 'spread': '46.0545', 'groupId': 'OG000'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.069', 'spread': '45.1349', 'groupId': 'OG000'}]}]}, {'title': 'Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.973', 'spread': '64.3206', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Days 28, 56 and 84', 'description': 'CCyR was based on the prevalence of Ph+ metaphases among cells in metaphase on a BM aspirate. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. Trough plasma concentration of participants who had CCyR are presented in this outcome measure.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, "N" signifies number of participants evaluable for this outcome measure and "number analyzed (n)" signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Summary of Trough Plasma Concentration by Major Molecular Response (MMR) of Bosutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.050', 'spread': '51.9551', 'groupId': 'OG000'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.437', 'spread': '43.6019', 'groupId': 'OG000'}]}]}, {'title': 'Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.081', 'spread': '72.1500', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Days 28, 56 and 84', 'description': 'MMR was defined as a ratio of BCR-ABL/ABL \\<=0.1% on the international scale (\\>=3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts) by quantitative RT-qPCR. Trough plasma concentration of participants who had MMR are presented in this outcome measure.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, "N" signifies number of participants evaluable for this outcome measure and "n" signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Summary of Trough Plasma Concentration by Presence of Grade 1 or Higher Adverse Events (AEs) of Bosutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'title': 'Day 28: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.402', 'spread': '55.5005', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Thrombocytopenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.529', 'spread': '40.9949', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.779', 'spread': '60.6257', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.011', 'spread': '42.6437', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.684', 'spread': '60.7208', 'groupId': 'OG000'}]}]}, {'title': 'Day 56: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.834', 'spread': '42.6621', 'groupId': 'OG000'}]}]}, {'title': 'Day 56: Thrombocytopenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.327', 'spread': '43.2859', 'groupId': 'OG000'}]}]}, {'title': 'Day 56: Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.016', 'spread': '38.7506', 'groupId': 'OG000'}]}]}, {'title': 'Day 56: Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.626', 'spread': '44.4007', 'groupId': 'OG000'}]}]}, {'title': 'Day 56: Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.980', 'spread': '45.9064', 'groupId': 'OG000'}]}]}, {'title': 'Day 84: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.269', 'spread': '64.6462', 'groupId': 'OG000'}]}]}, {'title': 'Day 84: Thrombocytopenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.585', 'spread': '33.6674', 'groupId': 'OG000'}]}]}, {'title': 'Day 84: Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.080', 'spread': '69.5237', 'groupId': 'OG000'}]}]}, {'title': 'Day 84: Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.702', 'spread': '61.6179', 'groupId': 'OG000'}]}]}, {'title': 'Day 84: Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.949', 'spread': '55.3041', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Days 28, 56 and 84', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening or disabling; urgent intervention indicated; Grade 5= death. Trough plasma concentration of participants who had grade 1 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separately for each preferred term of AE.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, "N" signifies number of participants evaluable for this outcome measure and "n" signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Summary of Trough Plasma Concentration by Presence of Grade 3 or Higher Adverse Events (AEs) of Bosutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'title': 'Day 28: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.769', 'spread': '102.6181', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Thrombocytopenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.220', 'spread': '36.3461', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.150', 'spread': '43.3246', 'groupId': 'OG000'}]}]}, {'title': 'Day 28: Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.663', 'spread': '21.5799', 'groupId': 'OG000'}]}]}, {'title': 'Day 56: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.513', 'spread': '45.2672', 'groupId': 'OG000'}]}]}, {'title': 'Day 56: Thrombocytopenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.853', 'spread': '34.3892', 'groupId': 'OG000'}]}]}, {'title': 'Day 56: Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.925', 'spread': '18.8656', 'groupId': 'OG000'}]}]}, {'title': 'Day 56: Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.200', 'spread': 'NA', 'comment': 'As only 1 participant was analyzed, standard deviation could not be calculated.', 'groupId': 'OG000'}]}]}, {'title': 'Day 84: Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.782', 'spread': '46.3006', 'groupId': 'OG000'}]}]}, {'title': 'Day 84: Thrombocytopenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.623', 'spread': '35.3084', 'groupId': 'OG000'}]}]}, {'title': 'Day 84: Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.967', 'spread': '19.2542', 'groupId': 'OG000'}]}]}, {'title': 'Day 84: Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.400', 'spread': 'NA', 'comment': 'As only 1 participant was analyzed, standard deviation could not be calculated.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Days 28, 56 and 84', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on NCI CTCAE version 4.0. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening or disabling; urgent intervention indicated; Grade 5= death. Trough plasma concentration of participants who had grade 3 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separately for each preferred term of AE.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, "N" signifies number of participants evaluable for this outcome measure and "n" signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment (up to Month 60)', 'description': 'Criteria for vital signs abnormalities: systolic blood pressure \\<80 millimeter of mercury (mmHg), \\>210 mmHg; diastolic blood pressure \\<40 mmHg, \\>130 mmHg; heart rate \\<40 beats per minute (bpm), \\>150 bpm; temperature \\<32 degree celsius, \\>40 degree celsius; weight \\>=10% increase from baseline, \\>=10% decrease from baseline. The number of participants with any vital sign abnormalities during On-treatment period are reported. On-Treatment was defined as values collected after the date of the first dose of test article until the last date of test article +28 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. Here, "N" signifies number of participants evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Version 4.03', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment (up to Month 60)', 'description': 'Laboratory parameters included hematological (haemoglobin, lymphocytes \\[absolute\\], neutrophils \\[absolute\\], platelets and leukocytes) and biochemistry (albumin, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, amylase, bilirubin, creatinine kinase, calcium, creatinine, glucose, potassium, lipase, magnesium, phosphate, sodium, urate) parameters. Abnormalities in laboratory tests were graded by NCI CTCAE version 4.03 as Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. The number of participants with laboratory test abnormalities were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment (up to Month 60)', 'description': "Criteria for ECG abnormalities included heart rate: increase of \\>15 bpm from baseline value and \\>=120 bpm, decrease of \\>15 bpm from baseline value and \\<=45 bpm; PR interval: change of \\>=20 msec from baseline value and \\>=220 milliseconds (msec); QRS interval \\>=120 msec; QTcB interval \\>500 msec, increase of \\>60 msec from baseline; \\>450 msec (Men) or \\>470 msec (Women). QT interval using Fridericia's correction (QTcF) \\>500 msec, increase of \\>60 msec from baseline, \\>450 msec (Men) or \\>470 msec (Women). The number of participants with ECG abnormalities during On-treatment period are reported. On-Treatment was defined as values collected after the date of the first dose of test article up until the last date of test article +28 days.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. Here, "N" signifies number of participants evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment (up to Month 60)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment-Emergent Adverse Events by National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'OG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment (up to Month 60)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on NCI CTCAE version 4.0. Grade 1 =mild; Grade 2 =moderate; Grade 3 =severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4 =life-threatening or disabling, urgent intervention indicated; Grade 5 =death. Treatment-emergent events were events between first dose of study drug and up to 60 months that were absent before treatment that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 adverse event, only the maximum CTCAE was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive chronic myeloid leukemia (CML) received bosutinib tablets at a dose of 400 milligram (mg), orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'FG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '268'}, {'groupId': 'FG001', 'numSubjects': '268'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '268'}, {'groupId': 'FG001', 'numSubjects': '265'}]}, {'type': 'mITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}, {'groupId': 'FG001', 'numSubjects': '241'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '231'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Investigator Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Deceased', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '536', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bosutinib', 'description': 'Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'BG001', 'title': 'Imatinib', 'description': 'Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.8', 'spread': '15.40', 'groupId': 'BG000'}, {'value': '50.9', 'spread': '14.43', 'groupId': 'BG001'}, {'value': '50.9', 'spread': '14.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat population: All randomized participants with study drug assignments designated according to initial randomization.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'NOTE: Value was Open Label in old format; This study has an open-label design. Although most efficacy studies have a double blind design, this is not feasible in this trial, due to the complexity of the dose reduction and dose escalation schemes with tablets of various sizes, dosage strengths, as well as the number of tablets that would be required daily. However, the opportunity for bias is mitigated by the use of objective outcome measures (MMR, CCyR, CHR). The Investigators will be instructed to ensure that laboratory/pathology personnel are blinded to treatment information. For these reasons, an open-label, randomized study is appropriate.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 536}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-16', 'studyFirstSubmitDate': '2014-05-01', 'resultsFirstSubmitDate': '2018-07-13', 'studyFirstSubmitQcDate': '2014-05-02', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-15', 'studyFirstPostDateStruct': {'date': '2014-05-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Summary of Trough Plasma Concentration by Complete Cytogenetic Response (CCyR) of Bosutinib', 'timeFrame': 'Pre-dose on Days 28, 56 and 84', 'description': 'CCyR was based on the prevalence of Ph+ metaphases among cells in metaphase on a BM aspirate. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. Trough plasma concentration of participants who had CCyR are presented in this outcome measure.'}, {'measure': 'Summary of Trough Plasma Concentration by Major Molecular Response (MMR) of Bosutinib', 'timeFrame': 'Pre-dose on Days 28, 56 and 84', 'description': 'MMR was defined as a ratio of BCR-ABL/ABL \\<=0.1% on the international scale (\\>=3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts) by quantitative RT-qPCR. Trough plasma concentration of participants who had MMR are presented in this outcome measure.'}, {'measure': 'Summary of Trough Plasma Concentration by Presence of Grade 1 or Higher Adverse Events (AEs) of Bosutinib', 'timeFrame': 'Pre-dose on Days 28, 56 and 84', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening or disabling; urgent intervention indicated; Grade 5= death. Trough plasma concentration of participants who had grade 1 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separately for each preferred term of AE.'}, {'measure': 'Summary of Trough Plasma Concentration by Presence of Grade 3 or Higher Adverse Events (AEs) of Bosutinib', 'timeFrame': 'Pre-dose on Days 28, 56 and 84', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on NCI CTCAE version 4.0. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening or disabling; urgent intervention indicated; Grade 5= death. Trough plasma concentration of participants who had grade 3 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separately for each preferred term of AE.'}, {'measure': 'Number of Participants With Vital Signs Abnormalities', 'timeFrame': 'Baseline up to end of treatment (up to Month 60)', 'description': 'Criteria for vital signs abnormalities: systolic blood pressure \\<80 millimeter of mercury (mmHg), \\>210 mmHg; diastolic blood pressure \\<40 mmHg, \\>130 mmHg; heart rate \\<40 beats per minute (bpm), \\>150 bpm; temperature \\<32 degree celsius, \\>40 degree celsius; weight \\>=10% increase from baseline, \\>=10% decrease from baseline. The number of participants with any vital sign abnormalities during On-treatment period are reported. On-Treatment was defined as values collected after the date of the first dose of test article until the last date of test article +28 days.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Version 4.03', 'timeFrame': 'Baseline up to end of treatment (up to Month 60)', 'description': 'Laboratory parameters included hematological (haemoglobin, lymphocytes \\[absolute\\], neutrophils \\[absolute\\], platelets and leukocytes) and biochemistry (albumin, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, amylase, bilirubin, creatinine kinase, calcium, creatinine, glucose, potassium, lipase, magnesium, phosphate, sodium, urate) parameters. Abnormalities in laboratory tests were graded by NCI CTCAE version 4.03 as Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. The number of participants with laboratory test abnormalities were reported.'}, {'measure': 'Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Baseline up to end of treatment (up to Month 60)', 'description': "Criteria for ECG abnormalities included heart rate: increase of \\>15 bpm from baseline value and \\>=120 bpm, decrease of \\>15 bpm from baseline value and \\<=45 bpm; PR interval: change of \\>=20 msec from baseline value and \\>=220 milliseconds (msec); QRS interval \\>=120 msec; QTcB interval \\>500 msec, increase of \\>60 msec from baseline; \\>450 msec (Men) or \\>470 msec (Women). QT interval using Fridericia's correction (QTcF) \\>500 msec, increase of \\>60 msec from baseline, \\>450 msec (Men) or \\>470 msec (Women). The number of participants with ECG abnormalities during On-treatment period are reported. On-Treatment was defined as values collected after the date of the first dose of test article up until the last date of test article +28 days."}, {'measure': 'Number of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation', 'timeFrame': 'Baseline up to end of treatment (up to Month 60)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events by National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.0)', 'timeFrame': 'Baseline up to end of treatment (up to Month 60)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on NCI CTCAE version 4.0. Grade 1 =mild; Grade 2 =moderate; Grade 3 =severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4 =life-threatening or disabling, urgent intervention indicated; Grade 5 =death. Treatment-emergent events were events between first dose of study drug and up to 60 months that were absent before treatment that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 adverse event, only the maximum CTCAE was reported.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With Major Molecular Response (MMR) at Month 12', 'timeFrame': 'Month 12', 'description': 'MMR was defined as a ratio of breakpoint cluster region to abelson (BCR-ABL/ABL) less than or equal to (\\<=) 0.1 percent (%) on the international scale (IS) (greater than or equal to \\[\\>=\\] 3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts \\[\\>=3000 ABL required\\]) by quantitative reverse transcriptase polymerase chain reaction (RT-qPCR). The percentage of participants with MMR at Month 12 are reported.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Major Molecular Response (MMR) Up to Month 18', 'timeFrame': 'Up to Month 18', 'description': 'MMR was defined as a ratio of BCR-ABL/ABL \\<=0.1% on the international scale (\\>=3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts \\[\\>=3000 ABL required\\]) by quantitative RT-qPCR. The percentage of participants with MMR for up to Month 18 are reported.'}, {'measure': 'Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 48', 'timeFrame': 'Month 48', 'description': 'The Kaplan-Meier curve was generated based on the first date of MMR until the date of the confirmed loss of MMR or censoring, objectively documented, for responders only. Confirmed loss of MMR was BCR-ABL/ABL IS ratio \\>0.1% in association with a \\>=5-fold increase in BCR-ABL/ABL IS ratio from the lowest value achieved up to that time-point confirmed by a second assessment at least 28 days later. Treatment discontinuation due to suboptimal response/treatment failure, progressive disease (PD) or death due to PD within 28 days of last dose were considered confirmed loss of MMR. PD was defined as disease progression to accelerated phase (AP) or blast phase (BP) CML.'}, {'measure': 'Percentage of Participants With Complete Cytogenetic Response (CCyR) Up to Month 12', 'timeFrame': 'Up to Month 12', 'description': 'Complete Cytogenetic Response (CCyR) was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. The percentage of participants with CCyR for up to Month 12 are reported.'}, {'measure': 'Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 48', 'timeFrame': 'Month 48', 'description': 'The Kaplan-Meier curve was generated based on the first date of CCyR until the date of the confirmed loss of CCyR or censoring, objectively documented, for responders only. Confirmed loss of CCyR was the presence of at least one Ph+ metaphase confirmed by a second assessment at least 28 days later. Treatment discontinuation due to suboptimal response/treatment failure, PD or death due to PD within 28 days of last dose were considered confirmed loss of CCyR. PD was defined as disease progression to AP or BP CML.'}, {'measure': 'Cumulative Incidence of Event Free Survival (EFS) Events', 'timeFrame': 'Up to Month 60', 'description': 'EFS was defined as time from randomization to death due to any cause, transformation to AP or BP at any time, confirmed loss of complete hematologic response (CHR), confirmed loss of CCyR or censoring. Loss of CHR was defined as a hematologic assessment of non-CHR (chronic phase, AP, or BP) confirmed by 2 assessments at least 4 weeks apart. Loss of CHR was defined as appearance of any of the following: WBC count that rises to \\>20.0\\*10\\^9/L, platelet count rises to \\>=600\\*10\\^9/L, appearance of palpable spleen or other extramedullary involvement proven by biopsy, appearance of 5% myelocytes in peripheral blood, appearance of blasts or promyelocytes in peripheral blood. Loss of CCyR was defined as at least 1 Ph+ metaphase from analysis of \\<100 metaphases confirmed by follow up cytogenetic analysis after 1 month. Cumulative incidence of EFS was defined as percentage of participants with EFS event at Month 60 and was adjusted for competing risk of treatment discontinuation without event.'}, {'measure': 'Overall Survival (OS) Rate', 'timeFrame': 'Up to Month 60', 'description': 'OS was defined as the time (in months) from randomization to the occurrence of death due to any cause or censoring. Kaplan-meier analysis was used for determination of OS. Percentage of participants who were alive were estimated in this outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leukemia', 'Myelogenous', 'Chronic', 'BCR-ABL Positive', 'Bosutinib', 'Leukemia, Myeloid', 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive', 'Philadelphia Chromosome', 'Neoplasms by Histologic Type', 'Bone Marrow Diseases', 'Hematologic Diseases', 'Translocation, Genetic', 'Pathologic Processes', 'Imatinib', 'Therapeutic Uses', 'Pharmacologic Actions', 'Molecular Mechanisms of Pharmacological Action'], 'conditions': ['Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive']}, 'referencesModule': {'references': [{'pmid': '37553873', 'type': 'DERIVED', 'citation': 'Garrett M, Knight B, Cortes JE, Deininger MW. Population modeling of bosutinib exposure-response in patients with newly diagnosed chronic phase chronic myeloid leukemia. Cancer Med. 2023 Sep;12(17):17981-17992. doi: 10.1002/cam4.6439. Epub 2023 Aug 8.'}, {'pmid': '35643868', 'type': 'DERIVED', 'citation': 'Brummendorf TH, Cortes JE, Milojkovic D, Gambacorti-Passerini C, Clark RE, le Coutre P, Garcia-Gutierrez V, Chuah C, Kota V, Lipton JH, Rousselot P, Mauro MJ, Hochhaus A, Hurtado Monroy R, Leip E, Purcell S, Yver A, Viqueira A, Deininger MW; BFORE study investigators. Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial. Leukemia. 2022 Jul;36(7):1825-1833. doi: 10.1038/s41375-022-01589-y. Epub 2022 May 28.'}, {'pmid': '35235189', 'type': 'DERIVED', 'citation': 'Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.'}, {'pmid': '33851349', 'type': 'DERIVED', 'citation': 'Chuah C, Koh LP, Numbenjapon T, Zang DY, Ong KH, Do YR, Ohkura M, Ono C, Viqueira A, Cortes JE, Brummendorf TH. Efficacy and safety of bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia in the Asian subpopulation of the phase 3 BFORE trial. Int J Hematol. 2021 Jul;114(1):65-78. doi: 10.1007/s12185-021-03144-4. Epub 2021 Apr 13.'}, {'pmid': '29091516', 'type': 'DERIVED', 'citation': 'Cortes JE, Gambacorti-Passerini C, Deininger MW, Mauro MJ, Chuah C, Kim DW, Dyagil I, Glushko N, Milojkovic D, le Coutre P, Garcia-Gutierrez V, Reilly L, Jeynes-Ellis A, Leip E, Bardy-Bouxin N, Hochhaus A, Brummendorf TH. Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial. J Clin Oncol. 2018 Jan 20;36(3):231-237. doi: 10.1200/JCO.2017.74.7162. Epub 2017 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.', 'detailedDescription': 'The study will be open for enrollment until the planned number of approximately 500 Philadelphia Chromosome Positive (Ph+) patients have been randomized (approximately 250 Ph+ patients in each treatment arm; a total of approximately 530 Ph+ and Ph- patients). All patients will be treated and/or followed for approximately 5 years (240 weeks) after randomization until the study has closed. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 5 years (240 weeks) after randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Molecular diagnosis of CP CML of ≤ 6 months (from initial diagnosis).\n2. Adequate hepatic, renal and pancreatic function.\n3. Age ≥ 18 years.\n\nExclusion Criteria:\n\n1. Any prior medical treatment for CML, including tyrosine kinase inhibitors (TKIs), with the exception of hydroxyurea and/or anagrelide treatment, which are permitted for up to 6 months prior to study entry (signature of ICF) if suitably approved for use in the subject's region.\n2. Any past or current Central Nervous System (CNS) involvement, including leptomeningeal leukemia.\n3. Extramedullary disease only.\n4. Major surgery or radiotherapy within 14 days of randomization.\n5. History of clinically significant or uncontrolled cardiac disease.\n6. Known seropositivity to human immunodeficiency virus (HIV), current acute or chronic hepatitis B (hepatitis B surface-antigen positive), hepatitis C, cirrhosis or evidence of decompensated liver disease. Patients with resolved Hepatitis B can be included.\n7. Recent or ongoing clinically significant GI disorder, e.g. Crohn's Disease, Ulcerative Colitis, or prior total or partial gastrectomy.\n8. History of another malignancy within 5 years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered adequately treated and currently in complete remission for at least l2 months.\n9. Current, or recent (within 30 days, or 5 half-lives of investigational product) participation in other clinical trials of investigational agents and/or containing interventional procedures deemed contrary to the objectives and conduct of this trial."}, 'identificationModule': {'nctId': 'NCT02130557', 'briefTitle': 'A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A MULTICENTER PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA', 'orgStudyIdInfo': {'id': 'AV001'}, 'secondaryIdInfos': [{'id': '2013-005101-31', 'type': 'EUDRACT_NUMBER'}, {'id': 'B1871053', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bosutinib', 'description': 'Bosutinib, 400 mg, oral administration once a day', 'interventionNames': ['Drug: Bosutinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Imatinib', 'description': 'Imatinib, 400 mg, oral administration once a day', 'interventionNames': ['Drug: Imatinib']}], 'interventions': [{'name': 'Bosutinib', 'type': 'DRUG', 'description': 'Bosutinib (Bosulif®) is an orally bioavailable, potent, multi-targeted, dual Src-Abl tyrosine kinase inhibitor (TKI) that has been approved for the treatment of adult patients with Philadelphia positive (Ph+) chronic phase (CP), accelerated phase (AP) and blast phase (BP) chronic myelogenous leukemia (CML) previously treated with other TKI inhibitor therapy.\\[1\\] This study will investigate the use of bosutinib as first-line treatment for patients with Ph+ CP CML.', 'armGroupLabels': ['Bosutinib']}, {'name': 'Imatinib', 'type': 'DRUG', 'description': 'Imatinib mesylate (referred to in this protocol as imatinib) is an inhibitor of the BCR-ABL kinase and been the standard first-line therapy for patients with chronic-phase CML. Imatinib was granted approval by the European Commission in November 2001 and by the FDA in December 2002 for the treatment of newly diagnosed patients with CP Ph+ CML based on results from the IRIS trial.\n\nImatinib is considered the standard of care for both first-line and later line settings, and consequently is an appropriate active comparator.', 'armGroupLabels': ['Imatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Cancer Medical Center, Inc.', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute, Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '96819', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kaiser Permanente Hawaii', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Saint Alphonsus Regional Medical Center, Cancer Care Center', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Saint Alphonsus Regional Medical Center', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83605', 'city': 'Caldwell', 'state': 'Idaho', 'country': 'United States', 'facility': 'Saint Alphonsus Caldwell Cancer Care Center', 'geoPoint': {'lat': 43.66294, 'lon': -116.68736}}, {'zip': '83686', 'city': 'Nampa', 'state': 'Idaho', 'country': 'United States', 'facility': 'Saint Alphonsus Medical Center Nampa', 'geoPoint': {'lat': 43.54072, 'lon': -116.56346}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60621', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'John H. 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