{"analyses":[{"ciLowerLimit":"2.046","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.565","estimateComment":"An odds ratio \\> 1 means better clinical benefit response in favor of palbociclib plus fulvestrant arm.","groupDescription":"The exact test is testing the null hypothesis that the odds ratio of objective response rate is less than or equal to 1 vs. the alternative hypothesis that the odds ratio of objective response rate is greater than 1. An Odds Ratio \\>1 means better response in favor of palbociclib plus fulvestrant arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","pValueComment":"The p-value was not adjusted for multiple comparisons. The priori threshold for statistical significance is 1-sided, alpha=0.025.","paramType":"Odds Ratio (OR)","paramValue":"3.016","statisticalComment":"The 1-sided p-value is from the stratified exact test.","statisticalMethod":"Exact test (1-sided)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"61.0","upperLimit":"71.2","value":"66.3"},{"groupId":"OG001","lowerLimit":"32.3","upperLimit":"47.3","value":"39.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"347"},{"groupId":"OG001","value":"174"}],"units":"Participants"}],"description":"CBR is defined as the overall complete response (CR), partial response (PR) , or stable disease (SD) ≥24 weeks according to the RECIST version 1.1. Clinical Benefit Response Rate (CBRR) is defined as the proportion of participants with CR, PR, or SD ≥24 weeks relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received antitumor treatment other than the study medication prior to reaching a CR or PR, a best response of SD ≥24 weeks, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR and a best response of SD ≥24 weeks was counted as non-responders in the assessment of CBR. Per RECIST v1.1 for target lesions and assessed by MRI: CR, disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.","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":"NUMBER","populationDescription":"The 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. Randomized participants with measurable disease at baseline was also included.","reportingStatus":"POSTED","timeFrame":"From randomization until end of treatment (assessed up to 2 years)","title":"Clinical Benefit Response (CBR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}