{"analyses":[{"ciLowerLimit":"0.65","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.95","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0067","paramType":"Hazard Ratio (HR)","paramValue":"0.78","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.74","upperLimit":"8.18","value":"7.00"},{"groupId":"OG001","lowerLimit":"5.49","upperLimit":"6.90","value":"5.78"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"284"},{"groupId":"OG001","value":"285"}],"units":"Participants"}],"description":"PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)","id":"OG000","title":"Everolimus + Vinorelbine + Trastuzumab"},{"description":"Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)","id":"OG001","title":"Placebo + Vinorelbine + Trastuzumab"}],"paramType":"MEDIAN","populationDescription":"The Full Analysis Set (FAS) consisted of all randomized patients.","reportingStatus":"POSTED","timeFrame":"Every 6 weeks until disease progression or death which ever occurred first up to about 41 months","title":"Progressive-free Survival (PFS) Per Investigator Assessment","type":"PRIMARY","unitOfMeasure":"months"}