{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.29","pValueComment":"Two-sided.","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"13"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}],"units":"Participants"}],"description":"Grade 3 or higher serious adverse event. Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.","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":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Up to 6 years","title":"Number of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"Participants"}