{"analyses":[{"groupDescription":"Statistical results are for the full randomized population (n = 54). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction)","groupIds":["OG000","OG001"],"nonInferiorityComment":"Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups","nonInferiorityType":"SUPERIORITY","pValue":"0.5","pValueComment":"Yate's continuity correction was applied because of the number of subjects and successes (n = 4)","statisticalMethod":"One-sided Proportions Test"},{"groupDescription":"Statistical results are for the Liposarcoma group (n = 16). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for the secondary endpoints. Given the study closed early due to slow enrollment we do not anticipate detecting a statistical difference between the groups.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3","pValueComment":"Yate's continuity correction was applied because of small number of participants (n = 16) and successes (n = 2).","statisticalMethod":"One-sided Proportion Test"},{"groupDescription":"Statistical results are for the Other Sarcoma group (n = 38). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.8","pValueComment":"Yate's continuity correction was applied because of the small number of participants and successes (n = 2).","statisticalMethod":"One-sided Proportion Test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.9","upperLimit":"22.8","value":"6.9"},{"groupId":"OG001","lowerLimit":"1.0","upperLimit":"26.0","value":"8.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"title":"All randomized participants"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.8","upperLimit":"60","value":"22.2"},{"comment":"No participants achieved overall objective response, making the confidence interval not estimable","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"title":"Liposarcoma participants"},{"categories":[{"measurements":[{"comment":"No participants achieved overall objective response, making the confidence interval not estimable","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"0"},{"groupId":"OG001","lowerLimit":"1.4","upperLimit":"34.7","value":"11.1"}]}],"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":"Response is evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, where RECIST combines assessments for target, non-target and presence of new lesions. Best Overall Objective Response is the sum of all CR+PR divided by all randomized participants, where the strongest recorded response is used for the evaluation (CR\\>PR\\>SD\\>PD). Objective response (CR+PR) requires at least a 30% decrease in the sum of the largest diameter target lesions (with respective to the baseline sum); disappearance of all or persistence of one or more non-target lesions, maintenance of tumor marker levels above normal limits, and no new lesions. Estimated odds ratio of best overall objective response are reported with 95% confidence interval for the two histologic sarcoma subgroups (liposarcoma vs all other eligible soft tissue sarcoma subtypes). One-sided proportions test is used to determine whether best overall objective response is greater for the gemcitabine plus pazopanib group.","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":"NUMBER","populationDescription":"All randomized participants.","reportingStatus":"POSTED","timeFrame":"Best overall objective response recorded from the start of treatment until disease progression/recurrence assessed up to 3 years","title":"Percentage of Participants Achieving Best Overall Objective Response (CR+PR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}