{"analyses":[{"ciLowerLimit":"0.59","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.01","estimateComment":"Reference arm = Sorafenib Alone","groupDescription":"Original design: Hypothesized 28% reduction (HR=0.72) with SBRT (corresponds to median OS = 14.5 months). Assuming an exponential distribution and constant hazards, 292 patients were required to reach 238 OS events, with 80% statistical power, a 1-sided α of 0.05. Revised design (see limitations/caveats): For same above hypotheses, at least 155 OS events from 193 randomized patients provided 65% statistical power, with a 1-sided α of 0.05.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0554","paramType":"Hazard Ratio (HR)","paramValue":"0.77","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.62","upperLimit":"14.3","value":"12.30"},{"groupId":"OG001","lowerLimit":"11.42","upperLimit":"19.15","value":"15.85"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"85"}],"units":"Participants"}],"description":"An event for overall survival (OS) is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 153 deaths were reported.","dispersionType":"90% Confidence Interval","groups":[{"description":"400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Sorafenib Alone"},{"description":"27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"SBRT Followed by Sorafenib"}],"paramType":"MEDIAN","populationDescription":"Eligible participants","reportingStatus":"POSTED","timeFrame":"From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.","title":"Overall Survival","type":"PRIMARY","unitOfMeasure":"months"}