{"analyses":[{"ciLowerLimit":"0.72","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.06","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1707","paramType":"Hazard Ratio (HR)","paramValue":"0.87","statisticalComment":"Stratified log rank","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.5","upperLimit":"16.2","value":"14.5"},{"groupId":"OG001","lowerLimit":"12.1","upperLimit":"16.2","value":"14.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"254"}],"units":"Participants"}],"description":"Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.The stratified log-rank statistic will be the primary analysis to compare the two treatment arms on OS with the stratification factors: presence of visceral metastases (no, yes) and prior chemotherapy (no, yes). In addition, the proportional hazards model will be used to assess the importance of the treatment arm adjusting on patient characteristics, stratification variables and other important covariates in predicting OS.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm II (GCB)"},{"description":"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Arm I (GCP)"}],"paramType":"MEDIAN","populationDescription":"Intent to treat (ITT) analysis population","reportingStatus":"POSTED","timeFrame":"From date of randomization to date of death due to any cause, assessed up to 7 years","title":"Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"months"}