{"analyses":[{"ciLowerLimit":"0.443","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.737","estimateComment":"Unstratified Cox proportional hazards model was used.","groupDescription":"Statistical analysis for ER positive","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.571","statisticalMethod":"Unstratified log-rank test"},{"ciLowerLimit":"0.218","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.751","estimateComment":"Unstratified Cox proportional hazards model was used.","groupDescription":"Statistical analysis for ER Negative","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0030","paramType":"Hazard Ratio (HR)","paramValue":"0.405","statisticalMethod":"Unstratified log-rank test"},{"ciLowerLimit":"0.416","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.680","estimateComment":"Unstratified Cox proportional 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(HR)","paramValue":"0.518","statisticalMethod":"Unstratified log-rank test"},{"ciLowerLimit":"0.392","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.364","estimateComment":"Unstratified Cox proportional hazards model was used.","groupDescription":"Statistical analysis for p16 Negative","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.3221","paramType":"Hazard Ratio (HR)","paramValue":"0.731","statisticalMethod":"Unstratified log-rank test"},{"ciLowerLimit":"0.455","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.742","estimateComment":"Unstratified Cox proportional hazards model was used.","groupDescription":"Statistical analysis for p16 HScore\\<175","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.581","statisticalMethod":"Unstratified log-rank test"},{"ciLowerLimit":"0.100","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.650","estimateComment":"Unstratified Cox proportional hazards model was used.","groupDescription":"Statistical analysis for p16 HScore\\>=175","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0022","paramType":"Hazard Ratio (HR)","paramValue":"0.255","statisticalMethod":"Unstratified log-rank test"},{"ciLowerLimit":"0.379","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.742","estimateComment":"Unstratified Cox proportional hazards model was used.","groupDescription":"Statistical analysis for Ki67 \\<=20%","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0002","paramType":"Hazard Ratio (HR)","paramValue":"0.530","statisticalMethod":"Unstratified log-rank test"},{"ciLowerLimit":"0.409","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.791","estimateComment":"Unstratified Cox proportional hazards model was used.","groupDescription":"Statistical analysis for Ki67 \\>20%","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0007","paramType":"Hazard Ratio (HR)","paramValue":"0.569","statisticalMethod":"Unstratified log-rank test"}],"classes":[{"categories":[{"measurements":[{"comment":"Not reached; insufficient number of participants with events.","groupId":"OG000","lowerLimit":"22.2","upperLimit":"NA","value":"24.9"},{"groupId":"OG001","lowerLimit":"12.9","upperLimit":"19.1","value":"16.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"338"},{"groupId":"OG001","value":"166"}],"units":"Participants"}],"title":"ER Positive"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.3","upperLimit":"22.0","value":"15.6"},{"groupId":"OG001","lowerLimit":"2.7","upperLimit":"11.1","value":"5.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"ER Negative"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"21.4","upperLimit":"25.7","value":"24.2"},{"groupId":"OG001","lowerLimit":"11.0","upperLimit":"16.5","value":"13.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"345"},{"groupId":"OG001","value":"167"}],"units":"Participants"}],"title":"Rb Positive"},{"categories":[{"measurements":[{"comment":"Not reached; insufficient number of participants with events.","groupId":"OG000","lowerLimit":"11.4","upperLimit":"NA","value":"NA"},{"comment":"Not reached; insufficient number of participants with events.","groupId":"OG001","lowerLimit":"2.9","upperLimit":"NA","value":"18.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Rb Negative"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"21.5","upperLimit":"27.6","value":"24.8"},{"groupId":"OG001","lowerLimit":"11.3","upperLimit":"16.8","value":"13.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"370"},{"groupId":"OG001","value":"179"}],"units":"Participants"}],"title":"Cyclin D1 Positive"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.2","upperLimit":"23.9","value":"11.1"},{"comment":"Not reached; insufficient number of participants with events.","groupId":"OG001","lowerLimit":"0.4","upperLimit":"NA","value":"8.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"10"}],"units":"Participants"}],"title":"Cyclin D1 Negative"},{"categories":[{"measurements":[{"comment":"Not reached; insufficient number of participants with events.","groupId":"OG000","lowerLimit":"21.5","upperLimit":"NA","value":"24.8"},{"groupId":"OG001","lowerLimit":"11.1","upperLimit":"16.8","value":"13.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"305"},{"groupId":"OG001","value":"161"}],"units":"Participants"}],"title":"p16 Positive"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.1","upperLimit":"24.9","value":"16.8"},{"comment":"Not reached; insufficient number of participants with events.","groupId":"OG001","lowerLimit":"8.1","upperLimit":"NA","value":"13.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"title":"p16 Negative"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"19.6","upperLimit":"25.7","value":"23.7"},{"groupId":"OG001","lowerLimit":"11.2","upperLimit":"16.8","value":"13.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"177"}],"units":"Participants"}],"title":"p16 H-Score<175"},{"categories":[{"measurements":[{"comment":"Not reached; insufficient number of participants with events.","groupId":"OG000","lowerLimit":"11.1","upperLimit":"NA","value":"24.2"},{"groupId":"OG001","lowerLimit":"1.5","upperLimit":"19.1","value":"5.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"p16 H-Score>=175"},{"categories":[{"measurements":[{"comment":"Not reached; insufficient number of participants with events.","groupId":"OG000","lowerLimit":"24.2","upperLimit":"NA","value":"27.6"},{"groupId":"OG001","lowerLimit":"13.7","upperLimit":"22.0","value":"16.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"216"},{"groupId":"OG001","value":"102"}],"units":"Participants"}],"title":"Ki67 <=20%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.8","upperLimit":"22.0","value":"17.5"},{"groupId":"OG001","lowerLimit":"5.6","upperLimit":"13.6","value":"8.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"83"}],"units":"Participants"}],"title":"Ki67 >20%"}],"denoms":[{"counts":[{"groupId":"OG000","value":"444"},{"groupId":"OG001","value":"222"}],"units":"Participants"}],"description":"PFS by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Positive is defined as H-Score \\>=1 and negative as H-Score \\<1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)\\*0 + (% at 1+)\\*1 + (% at 2+)\\*2 + (% at 3+)\\*3. H-Score values range from 0 to 300. ER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.","id":"OG000","title":"Palbociclib Plus Letrozole"},{"description":"Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.","id":"OG001","title":"Placebo Plus Letrozole"}],"paramType":"MEDIAN","populationDescription":"ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized. Here \"Number Analyzed\" signifies number of participants evaluable for specified rows.","reportingStatus":"POSTED","timeFrame":"From randomization until end of treatment (up to approximately 24 Months)","title":"PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)","type":"SECONDARY","unitOfMeasure":"Months"}