{"analyses":[{"groupDescription":"Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.83","statisticalComment":"Random coefficient model adjusted for baseline Motzer score, baseline PWB score and relative day of PWB completion.","statisticalMethod":"random coefficient model","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.17","value":"21.21"},{"groupId":"OG001","spread":"0.19","value":"21.16"}]}],"title":"Cycle 2, Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.17","value":"20.77"},{"groupId":"OG001","spread":"0.19","value":"20.72"}]}],"title":"Cycle 3, Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.19","value":"20.33"},{"groupId":"OG001","spread":"0.22","value":"20.28"}]}],"title":"Cycle 4, Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.24","value":"19.89"},{"groupId":"OG001","spread":"0.26","value":"19.84"}]}],"title":"Cycle 5, Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.17","value":"20.70"},{"groupId":"OG001","spread":"0.19","value":"20.65"}]}],"title":"Cycles 1-5 (Overall)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"451"},{"groupId":"OG001","value":"452"}],"units":"Participants"}],"description":"Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from \"0=not at all\" to \"4=very much\" and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL.","dispersionType":"Standard Error","groups":[{"description":"Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.","id":"OG000","title":"Sorafenib (Nexavar, BAY43-9006)"},{"description":"Subjects received matching placebo tablets administered orally twice a day. \\[until \\~31 May 2005\\]","id":"OG001","title":"Placebo"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.","reportingStatus":"POSTED","timeFrame":"From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.","title":"Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment","type":"SECONDARY","unitOfMeasure":"Scores on a scale"}