{"classes":[{"categories":[{"measurements":[{"comment":"Due to less follow up time and insufficient number of participants having duration response.","groupId":"OG000","lowerLimit":"8.3","upperLimit":"NA","value":"10.4"},{"comment":"Due to less follow up time and insufficient number of participants having duration response.","groupId":"OG001","lowerLimit":"5.6","upperLimit":"NA","value":"9.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"347"},{"groupId":"OG001","value":"174"}],"units":"Participants"}],"description":"DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as \\[the date response ended (ie, date of PD or death) - first CR or PR date + 1)\\]/30.4. Kaplan-Meier estimate of median of the DR is provided below. No inferential statistical analysis were done for DR. The DR was only calculated for the participants with a CR or 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":"MEDIAN","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.","reportingStatus":"POSTED","timeFrame":"From randomization until end of treatment (assessed up to 2 years)","title":"Duration of Response (DR)","type":"SECONDARY","unitOfMeasure":"Months"}