{"analyses":[{"ciLowerLimit":"0.318","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.560","estimateComment":"Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of the palbociclib plus fulvestrant arm.","groupDescription":"The primary hypothesis to be tested was H0: λ≥1 versus. HA: λ\\<1, where λ was the palbociclib plus fulvestrant: placebo plus fulvestrant hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Fulvestrant. The study was planned to have 90% power and control the type-I error rate at 0.025.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.000001","pValueComment":"The overall Type-I error rate was persevered at 1-sided 0.025 level for the analysis of the primary endpoint PFS by the Haybittle-Peto efficacy boundary. The priori threshold for statistical significance was 0.00135.","paramType":"Hazard Ratio (HR)","paramValue":"0.422","statisticalComment":"The log rank test stratified by sensitivity to prior hormonal therapy and the presence of visceral metastases based on the randomization information.","statisticalMethod":"Stratified Log Rank Test (1-sided)"}],"classes":[{"categories":[{"measurements":[{"comment":"Not estimable based on the Brookmeyer and Crowley method, because of insufficient number of participants with events.","groupId":"OG000","lowerLimit":"7.5","upperLimit":"NA","value":"9.2"},{"groupId":"OG001","lowerLimit":"3.5","upperLimit":"5.5","value":"3.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"347"},{"groupId":"OG001","value":"174"}],"units":"Participants"}],"description":"PFS is the time from the date of randomization to the date of the first documentation of objective progression of disease (PD)or death due to any cause in absence of documented PD. Participants lacking an evaluation of tumor response after randomization had their PFS time censored on the date of randomization with the duration of a day. Participants with documentation of PD or death after a long interval (2 or more incomplete or non-evaluable assessments) since the last tumor assessment were censored at the time of last objective assessment that did not show PD. The length of PFS was calculated as PFS time (months) =\\[progression/death date(censor date) - randomization date + 1\\]/30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors(RECIST v1.1) a 20% increase in the sum of diameters of target lesions and the sum must also demonstrate an absolute increase of at least 5mm or unequivocal progression of existing non-target lesions or the appearance of new lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.","id":"OG000","title":"Palbociclib + Fulvestrant"},{"description":"Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.","id":"OG001","title":"Placebo + Fulvestrant"}],"paramType":"MEDIAN","populationDescription":"The intent-to-treat (ITT) population or full analysis set included all participants who were randomized, with study intervention, regardless of whether participants received the study intervention or received a different drug from that to which they were randomized.","reportingStatus":"POSTED","timeFrame":"From randomization date to date of first documentation of progression or death (assessed up to 12 months)","title":"Progression-Free Survival (PFS) as Assessed by the Investigator","type":"PRIMARY","unitOfMeasure":"months"}