{"analyses":[{"ciLowerLimit":"0.40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.75","estimateComment":"Reference arm = Sorafenib Alone","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0001","pValueComment":"Two-sided significance level=0.05","paramType":"Hazard Ratio (HR)","paramValue":"0.55","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.42","upperLimit":"6.28","value":"5.49"},{"groupId":"OG001","lowerLimit":"7.53","upperLimit":"11.89","value":"9.22"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"85"}],"units":"Participants"}],"description":"Failure for progression-free survival (PFS) include death, new tumor thrombosis, progression of hepatocellular carcinoma (HCC) within liver excluding tumor thrombosis status, progression of distant Mets that were present at study entry, new HCC within liver including tumor thrombosis, and vascular thrombosis events =progression-new enhancing tumor thrombosis/progression-Increase in the volume of enhancing portion of thrombosis. PFS time is defined as the time from randomization to the date of first failure, date of death, or last known follow-up (censored). PFS rates are estimated by the Kaplan-Meier method. The protocol specifies only that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided as a summary of the distributions.","dispersionType":"95% 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":"NUMBER","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":"Progression-free Survival","type":"SECONDARY","unitOfMeasure":"percentage of participants"}