{"analyses":[{"ciLowerLimit":"0.581","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.821","estimateComment":"Hazard ratio of Albumin bound paclitaxel + gemcitabine / gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","pValueComment":"P-value was based on a stratified log-rank test by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis (yes vs no)","paramType":"Hazard Ratio (HR)","paramValue":".69","statisticalMethod":"Stratified Log-rank Test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.47","upperLimit":"5.95","value":"5.5"},{"groupId":"OG001","lowerLimit":"3.61","upperLimit":"4.04","value":"3.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"431"},{"groupId":"OG001","value":"430"}],"units":"Participants"}],"description":"Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.","dispersionType":"95% Confidence Interval","groups":[{"description":"Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest","id":"OG000","title":"Albumin-bound Paclitaxel (ABI-007)/Gemcitabine"},{"description":"Gemcitabine 1000 mg/m\\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)","id":"OG001","title":"Gemcitabine"}],"paramType":"MEDIAN","populationDescription":"Intent to Treat population (ITT population) consisted of all randomized participants.","reportingStatus":"POSTED","timeFrame":"Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.","title":"Progression-free Survival (PFS) by Independent Radiological Review (IRR)","type":"SECONDARY","unitOfMeasure":"months"}