{"analyses":[{"groupDescription":"Overall survival estimated among all randomized participants (n = 54)","groupIds":["OG000","OG001"],"nonInferiorityComment":"Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.","nonInferiorityType":"OTHER","pValue":"0.481","statisticalMethod":"Gehan-Wilcoxon"},{"groupDescription":"Overall survival compared between the two arms for the liposarcoma subgroup (n = 16)","groupIds":["OG000","OG001"],"nonInferiorityComment":"Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.","nonInferiorityType":"OTHER","pValue":"0.353","statisticalMethod":"Gehan-Wilcoxon"},{"groupDescription":"Overall survival comparison between the two treatment arms for the other sarcoma group (n = 38)","groupIds":["OG000","OG001"],"nonInferiorityComment":"Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.","nonInferiorityType":"OTHER","pValue":"0.408","statisticalMethod":"Gehan-Wilcoxon"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.6","upperLimit":"20.7","value":"11.0"},{"groupId":"OG001","lowerLimit":"6.1","upperLimit":"27.0","value":"15.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"title":"All Randomized"},{"categories":[{"measurements":[{"comment":"Upper limit was not estimable because there was no observed death time greater than the median survival that touched or crossed -1,96 using the log-transformation of the survival function (ref: Formula 4.5.5, Klein JP and Moeschberger ML, Survival Analysis: Techniques for censored and truncated data). This is likely due to small sample size (n = 9).","groupId":"OG000","lowerLimit":"11.0","upperLimit":"NA","value":"20.5"},{"comment":"Upper limit was not estimable due to small sample size (n = 7) and failure to cross the 25% line.","groupId":"OG001","lowerLimit":"3.5","upperLimit":"NA","value":"5.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"title":"Liposarcoma participants"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.6","upperLimit":"20.7","value":"10.2"},{"groupId":"OG001","lowerLimit":"7.6","upperLimit":"30.7","value":"17.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"title":"Other Sarcoma participants"}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"description":"Two treatment arms will be compared using a one-sided log-rank test stratified by sarcoma subtype and study site. Kaplan-Meier estimates and the survival curves for each treatment arm will be presented with the estimated hazard ratios and their associated confidence interval.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nGemcitabine: Given IV\n\nGemcitabine Hydrochloride: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPazopanib: Given PO\n\nPazopanib Hydrochloride: Given PO","id":"OG000","title":"Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride"},{"description":"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and placebo PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may receive single-agent pazopanib hydrochloride PO daily. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nGemcitabine: Given IV\n\nGemcitabine Hydrochloride: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPazopanib: Given PO\n\nPazopanib Hydrochloride: Given PO\n\nPlacebo Administration: Given PO","id":"OG001","title":"Gemcitabine Hydrochloride Plus Placebo"}],"paramType":"MEDIAN","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization to death due to any cause, or until last patient contact if the patient did not die, assessed up to 3 years","title":"Overall Survival","type":"SECONDARY","unitOfMeasure":"months"}