{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.93","upperLimit":"11.53","value":"8.31"},{"groupId":"OG001","lowerLimit":"5.55","upperLimit":"10.38","value":"7.29"}]}],"title":"Deterioration - global QoL domain by at least 10%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.31","upperLimit":"14.09","value":"11.96"},{"groupId":"OG001","lowerLimit":"8.31","upperLimit":"20.86","value":"12.48"}]}],"title":"Deterioration in the PF domain by at least 10%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.20","upperLimit":"17.28","value":"15.18"},{"groupId":"OG001","lowerLimit":"9.69","upperLimit":"16.36","value":"12.45"}]}],"title":"Deterioration in the EF domain by at least 10%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.18","upperLimit":"14.52","value":"11.33"},{"groupId":"OG001","lowerLimit":"8.31","upperLimit":"19.32","value":"13.11"}]}],"title":"Deterioration in the SF domain by at least 10%"}],"denoms":[{"counts":[{"groupId":"OG000","value":"284"},{"groupId":"OG001","value":"285"}],"units":"Participants"}],"description":"PRO = patient reported outcomes; Time to deterioration (≥ 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, \\& social functioning \\[EF, PF, \\& SF\\]). It contains 30 items \\& is composed of multi-item scales \\& single-item measures. These include 5 functional scales (physical, role, emotional, social \\& cognitive functioning), 3 symptom scales (fatigue, pain, nausea, \\& vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia \\& financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest \\& disclosed here.","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":"Baseline, until disease progression or death up to about 41 months","title":"PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)","type":"SECONDARY","unitOfMeasure":"months"}