{"analyses":[{"groupDescription":"Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.444","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.4","upperLimit":"17","value":"6.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"}],"units":"Participants"}],"title":"PD-L1 positive"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6","upperLimit":"9.7","value":"6.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"}],"units":"Participants"}],"title":"PD-L1 negative"}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"}],"units":"Participants"}],"description":"Correlation between the expression of PD-L1 with PFS during experimental treatment. Patients will be grouped based on the PD-L1 expression levels in PD-L1 positive or negative patients. Progression free survival will be assessed in both groups of patients and compared to identify potential statistically significant differences between groups.","dispersionType":"95% Confidence Interval","groups":[{"description":"Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.\n\nGemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.\n\nAtezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.\n\nGemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.\n\nCisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.","id":"OG000","title":"AUREA Single-arm"}],"paramType":"MEDIAN","populationDescription":"26 patients had no PD-L1 determined","reportingStatus":"POSTED","timeFrame":"PD-L1 expression measured at the end of the trial. PFS assessed Through study completion, average 2 years","title":"Progression Free Survival Measured by RECIST 1.1 in Patients Grouped According to Their PD-L1 Expression","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"months"}