{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.4","upperLimit":"10.5","value":"9.0"},{"groupId":"OG001","lowerLimit":"8.0","upperLimit":"10.3","value":"8.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"234"},{"groupId":"OG001","value":"235"}],"units":"Participants"}],"description":"Time until disease progression, death, or date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"All patients.","reportingStatus":"POSTED","timeFrame":"From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years","title":"Progression Free Survival (PFS) (Phase III)","type":"SECONDARY","unitOfMeasure":"Months"}