{"analyses":[{"ciLowerLimit":"0.53","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.11","groupDescription":"PFS per mRECIST - Strongly PD-L1 Positive Participants","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.07066","pValueComment":"One-sided p-value based on stratified log-rank test","paramType":"Hazard Ratio (HR)","paramValue":"0.77","statisticalComment":"Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.4","upperLimit":"3.7","value":"3.3"},{"groupId":"OG001","lowerLimit":"2.0","upperLimit":"3.7","value":"2.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"74"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per mRECIST, PD was defined was defined as at least 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. Per mRECIST, confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented was required for participants remaining on treatment following PD per RECIST 1.1. PFS per mRECIST was assessed by BICR in participants with strongly PD-L1 positive tumors (CPS ≥10%) up through the final analysis database cut-off date of 26-Oct-2017.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received paclitaxel 175 mg/m\\^2 intravenously (IV) or docetaxel 75 mg/m\\^2 IV or vinflunine 320 mg/m\\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).","id":"OG000","title":"Control"},{"description":"Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).","id":"OG001","title":"Pembrolizumab"}],"paramType":"MEDIAN","populationDescription":"The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months)","title":"PFS Per Modified RECIST (mRECIST) - Participants With Strongly PD-L1 Positive Tumors","type":"SECONDARY","unitOfMeasure":"Months"}