{"analyses":[{"ciLowerLimit":"0.56","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.36","estimateComment":"Adjusted for initial treatment (primary debulking surgery or neoadjuvant therapy followed by surgery) and planned chemotherapy regimen.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.31","pValueComment":"One-sided. The a priori threshold for statistical significance was \\<0.15.","paramType":"Cox Proportional Hazard","paramValue":"0.87","statisticalComment":"Stratified by initial treatment (primary debulking surgery or neoadjuvant therapy followed by surgery) and planned chemotherapy regimen.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.2","upperLimit":"23.5","value":"15.4"},{"groupId":"OG001","lowerLimit":"11.6","upperLimit":"18.0","value":"14.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}],"units":"Participants"}],"description":"Time to disease progression or death from any cause. Progression evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 and Gynecological Cancer Intergroup (GCIG) criteria. For example, progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity.\n\nmetformin hydrochloride: Given PO\n\nChemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.","id":"OG000","title":"Metformin Plus Chemotherapy"},{"description":"Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nChemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.","id":"OG001","title":"Placebo Plus Chemotherapy"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"Up to 6 years","title":"Progression Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"Months"}