{"analyses":[{"groupDescription":"Statistical results are for the full randomized population (n = 54). The study was originally designed with overall one-sided alpha of 5%, where a total of 73 patients (36 in the gemcitabine + placebo arm, and 37 in the gemcitabine + pazopanib arm) were required to achieve 80% power to detect a 2.5 month increase in median PFS (a hazard ratio of 0.55) between the two treatment arms. Study was closed early by the sponsor due to slow accrual and funds and thus was under powered.","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":"SUPERIORITY","pValue":"0.017","statisticalMethod":"Gehan-Wilcoxon"},{"groupDescription":"Comparison between the two arms for the liposarcoma subgroup","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":"0.195","statisticalMethod":"Gehan-Wilcoxon"},{"groupDescription":"Statistical results are for the 'other' sarcoma subgroup (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":"0.079","statisticalMethod":"Gehan-Wilcoxon"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.0","upperLimit":"8.5","value":"4.5"},{"groupId":"OG001","lowerLimit":"1.4","upperLimit":"4.3","value":"1.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"title":"All randomized"},{"categories":[{"measurements":[{"comment":"There were not sufficient events to define the upper limit of the confidence interval (two out of nine participants progressed)","groupId":"OG000","lowerLimit":"4.3","upperLimit":"NA","value":"8.9"},{"comment":"Due to the small sample size (n = 7) the upper confidence limit was not estimable (did not cross the 50% line)","groupId":"OG001","lowerLimit":"1.0","upperLimit":"NA","value":"1.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"title":"Liposarcoma"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.0","upperLimit":"8.8","value":"4.4"},{"groupId":"OG001","lowerLimit":"1.4","upperLimit":"4.6","value":"2.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"title":"Other Sarcoma"}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"description":"Compared using a one-sided Gehan-Wilcoxon test stratified by sarcoma subtype. Kaplan-Meier estimates for each treatment arm will be presented with the estimated hazard ratios and their associated confidence intervals. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the smallest sum on study) with an absolute increase of at least 5 mm (target lesions), or measurable increase in non-target lesions (unequivocal progression), or appearance of one or more new lesions.","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":"Calculated as the time from randomization to the first documented progression or death, whichever occurs first, or until time of last contact if no progression or death occurred, assessed up to 3 years","title":"Progression-free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}