{"analyses":[{"ciLowerLimit":"0.487","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.846","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":"Treatment with palbociclib plus fulvestrant significantly delayed TTD in pain symptom compared with placebo plus fulvestrant for unstratified analysis.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.001","pValueComment":"The priori threshold for statistical significance is 1-sided alpha=0.025. The p-value was not adjusted for multiple comparisons.","paramType":"Hazard Ratio (HR)","paramValue":"0.642","statisticalComment":"1-sided p-value from the unstratified log-rank test.","statisticalMethod":"Unstratified log-rank test (1-sided)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.2","upperLimit":"2.2","value":"1.9"},{"groupId":"OG001","lowerLimit":"1.0","upperLimit":"1.9","value":"1.0"}]}],"title":"25% quartile"},{"categories":[{"measurements":[{"comment":"Due to less follow-up time and insufficient number of participants with events.","groupId":"OG000","lowerLimit":"5.6","upperLimit":"NA","value":"8.0"},{"groupId":"OG001","lowerLimit":"2.3","upperLimit":"5.4","value":"2.8"}]}],"title":"50% quartile"}],"denoms":[{"counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"166"}],"units":"Participants"}],"description":"A time to event analysis was pre-specified for pain. An analysis of TTD in pain defined as time between baseline and first occurrence of increase of ≥10 points in pain. Deterioration will be defined increase in score of 10 points or greater from baseline. The Kaplan-Meier estimates of quartiles (time to deterioration) with 95% CI is mentioned below.","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 PRO -evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post -baseline PRO assessment prior to end of study treatment.","reportingStatus":"POSTED","timeFrame":"Baseline, Day 1 of Cycles 2 to 4, Day 1 of every alternate cycle after that until the end of treatment, as of 05 December 2014","title":"Time to Deterioration (TTD)","type":"SECONDARY","unitOfMeasure":"Months"}