{"analyses":[{"groupDescription":"Analysis performed using Fisher's exact test with mid p-value modification by subtracting half of the probability of the observed table from Fisher's p-value.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"25.79","upperLimit":"34.53","value":"30.0"},{"groupId":"OG001","lowerLimit":"12.95","upperLimit":"23.65","value":"17.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"443"},{"groupId":"OG001","value":"213"}],"units":"Participants"}],"description":"ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \\>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.","id":"OG000","title":"Durvalumab (MEDI4736)"},{"description":"Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"FAS (which included all randomized patients) with measureable disease at baseline, analyzed on an ITT basis.","reportingStatus":"POSTED","timeFrame":"Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.","title":"Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1","type":"SECONDARY","unitOfMeasure":"Percentage of patients"}