{"analyses":[{"ciLowerLimit":"1.563","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.603","estimateComment":"An Odds Ratio \\>1 means better response in favor of the 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":"2.783","statisticalComment":"The 1-sided p-value is from the stratified exact test.","statisticalMethod":"Exact test (1-sided)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"16.9","upperLimit":"25.7","value":"21.0"},{"groupId":"OG001","lowerLimit":"4.9","upperLimit":"13.8","value":"8.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"347"},{"groupId":"OG001","value":"174"}],"units":"Participants"}],"description":"OR is defined as the overall complete response (CR) or partial response (PR) according to the RECIST version 1.1 Objective Response Rate (ORR) is defined as the proportion of participants with CR or PR 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 anti-tumor treatment other than the study medication prior to reaching a CR or PR, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per response evaluation criteria in solid tumors criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of target lesions (longest for non-nodal and short axis for nodal target lesions); Overall Response (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":"Objective Response (OR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}