{"analyses":[{"ciLowerLimit":"0.388","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.605","estimateComment":"The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.","groupDescription":"The null hypothesis was that there was no difference between the 2 treatment groups, ie, that the hazard ratio is equal to 1. The alternative hypothesis was that progression free survival was longer in the carboplatin and gemcitabine + bevacizumab group, ie, that the hazard ratio is not equal to 1.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"A P-value \\< 0.05 was required for significance.","paramType":"Hazard Ratio (HR)","paramValue":"0.484","statisticalComment":"The analysis was stratified for time since the last platinum therapy (6-12, \\> 12 months) and cytoreductive surgery for recurrent disease (yes, no).","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.40","upperLimit":"12.71","value":"12.4"},{"groupId":"OG001","lowerLimit":"8.31","upperLimit":"9.66","value":"8.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"242"},{"groupId":"OG001","value":"242"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to disease progression (PD), as determined by the investigator, or death due to any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started; the appearance of 1 or more new lesions; and/or the unequivocal progression of existing non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.","dispersionType":"95% Confidence Interval","groups":[{"description":"Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.","id":"OG000","title":"Carboplatin and Gemcitabine + Bevacizumab"},{"description":"Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.","id":"OG001","title":"Carboplatin and Gemcitabine + Placebo"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).","reportingStatus":"POSTED","timeFrame":"From randomization through September 17, 2010 (up to 3 years, 5 months)","title":"Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)","type":"PRIMARY","unitOfMeasure":"Months"}