{"analyses":[{"ciLowerLimit":"13.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"29.2","estimateComment":"The difference in response rates and the 95% confidence intervals for response rates were computed using the normal approximation to the binomial distribution.","groupDescription":"The null hypothesis was that there was no difference in the percentage of patients with an objective response between the 2 treatment groups. The alternative hypothesis was that a larger percentage of patients had an objective response in the carboplatin and gemcitabine + bevacizumab group.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"A P-value \\< 0.05 was required for significance.","paramType":"Mean Difference (Final Values)","paramValue":"21.1","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":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"78.5"},{"groupId":"OG001","value":"57.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"242"},{"groupId":"OG001","value":"242"}],"units":"Participants"}],"description":"An objective response was the occurrence of either a partial response (PR) or complete response (CR). PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR: The disappearance of all target and non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.","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":"NUMBER","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":"Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}