{"analyses":[{"ciLowerLimit":"0.37","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.73","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.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2827","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.","paramType":"Hazard Ratio (HR)","paramValue":"0.80","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"91.1","upperLimit":"97.0","value":"94.9"},{"groupId":"OG001","lowerLimit":"90.1","upperLimit":"96.4","value":"94.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"241"}],"units":"Participants"}],"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.","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":"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.","reportingStatus":"POSTED","timeFrame":"Up to Month 60","title":"Overall Survival (OS) Rate","type":"SECONDARY","unitOfMeasure":"percentage of participants"}