{"analyses":[{"ciLowerLimit":"0.449","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.681","groupDescription":"The final analysis was planned at 378 PFS events, which would provide approximately 90% power assuming a hazard ratio (HR) of 0.703 at a one-sided α of 0.025.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"<0.0000001","pValueComment":"This is two sided P value and it is statistically significant.","paramType":"Hazard Ratio (HR)","paramValue":"0.553","statisticalComment":"Log rank test is stratified by endocrine sensitivity and natural of disease by interactive web response system (IWRS).","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.4","upperLimit":"19.3","value":"16.4"},{"groupId":"OG001","lowerLimit":"7.4","upperLimit":"11.4","value":"9.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"446"},{"groupId":"OG001","value":"223"}],"units":"Participants"}],"description":"PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.","dispersionType":"95% Confidence Interval","groups":[{"description":"Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.","id":"OG000","title":"Abemaciclib + Fulvestrant"},{"description":"Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.","id":"OG001","title":"Placebo + Fulvestrant"}],"paramType":"MEDIAN","populationDescription":"All randomized participants. Censored participants: Abemaciclib=224.","reportingStatus":"POSTED","timeFrame":"From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)","title":"Progression-Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"Months"}