{"analyses":[{"ciLowerLimit":"1.072","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.233","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).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0100","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.","paramType":"Odds Ratio (OR)","paramValue":"1.547","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"40.9","upperLimit":"53.4","value":"47.2"},{"groupId":"OG001","lowerLimit":"30.8","upperLimit":"43.0","value":"36.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"241"}],"units":"Participants"}],"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.","dispersionType":"95% Confidence Interval","groups":[{"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":"OG000","title":"Bosutinib"},{"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":"OG001","title":"Imatinib"}],"paramType":"NUMBER","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.","reportingStatus":"POSTED","timeFrame":"Month 12","title":"Percentage of Participants With Major Molecular Response (MMR) at Month 12","type":"PRIMARY","unitOfMeasure":"percentage of participants"}