{"analyses":[{"ciLowerLimit":"0.32","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.59","groupDescription":"Hazard ratios were estimated by Cox regression. Hazard ratios and log-rank p-values are using stratified methods by stratifying Visceral Disease, Endocrine Resistance, and Region.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.43","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.3","upperLimit":"20.5","value":"15"},{"groupId":"OG001","lowerLimit":"5.6","upperLimit":"9.3","value":"7.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"161"},{"groupId":"OG001","value":"164"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or death from any cause (whichever occurs first). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. Data for participants without the occurrence of PD or death as of the clinical cutoff date (CCOD) were censored at the time of the last tumor assessment prior to the CCOD. Median PFS was calculated using the Kaplan-Meier methodology.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.","id":"OG000","title":"Inavo+Palbo+Fulv"},{"description":"Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.","id":"OG001","title":"Pbo+Palbo+Fulv"}],"paramType":"MEDIAN","populationDescription":"FAS included all participants who were randomized to receive the treatment they were assigned.","reportingStatus":"POSTED","timeFrame":"Up to 3.7 years","title":"Progression-Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}