{"analyses":[{"ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.27472","groupDescription":"The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model. Historical data indicate that approximately 50% of people are obese (BMI\\>=30). For the purposes of examining the relationship, we will classify patients into two levels (high versus low) at the median BMI, which will increase the likelihood of detecting an interaction between metformin treatment and obesity.","groupIds":["OG000","OG001"],"nonInferiorityComment":"The null hypothesis is that there is no relationship between BMI and metformin treatment (i.e. the parameter associated with the interaction term of BMI \\* treatment is equal to 0).","nonInferiorityType":"EQUIVALENCE","pValue":"0.9482","paramType":"Cox Proportional Hazard","paramValue":"-0.01787","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.4957"},{"groupId":"OG001","value":"0.4979"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"234"},{"groupId":"OG001","value":"235"}],"units":"Participants"}],"description":"Obesity will be quantitative assessed by body mass index (BMI) and will be assessed for its predictive and prognostic significance. The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model.","groups":[{"description":"Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)"},{"description":"Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Arm II (Paclitaxel, Carboplatin, Placebo)"}],"paramType":"NUMBER","populationDescription":"All patients","reportingStatus":"POSTED","timeFrame":"Up to 5 years","title":"Level of Obesity","type":"SECONDARY","unitOfMeasure":"proportion of participants obese"}