{"analyses":[{"ciLowerLimit":"0.606","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.950","estimateComment":"Hazard ratio and CI calculated using stratified Cox proportional hazards model,adjusting for tumor,node and metastasis(TNM) stage, receipt of prophylactic cranial irradiation(PCI),with treatment as only covariate and ties handled by Efron approach.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.01608","paramType":"Hazard Ratio (HR)","paramValue":"0.76","statisticalComment":"The analysis was performed using the stratified log-rank test.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.2","upperLimit":"28.2","value":"16.6"},{"groupId":"OG001","lowerLimit":"7.4","upperLimit":"12.9","value":"9.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"266"}],"units":"Participants"}],"description":"PFS per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of objective disease progression (PD) or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir) - this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received durvalumab monotherapy (1500 mg for participants \\>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg for participants \\<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.","id":"OG000","title":"Durvalumab"},{"description":"Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"The FAS included all randomized participants.","reportingStatus":"POSTED","timeFrame":"Response evaluations performed every 8 weeks (q8w) ± 1 week up to 72 weeks, then every 12 weeks (q12w) ± 1 week up to 96 weeks, and then every 24 weeks (q24w) thereafter until PD, up to DCO date 15 January 2024 (a maximum of approximately 1936 days)","title":"Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1","type":"PRIMARY","unitOfMeasure":"months"}