{"analyses":[{"ciLowerLimit":"0.683","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.998","estimateComment":"The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0477","pValueComment":"The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.","paramType":"Hazard Ratio (HR)","paramValue":"0.83","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.809","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.175","estimateComment":"The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7885","pValueComment":"The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.","paramType":"Hazard Ratio (HR)","paramValue":"0.97","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.3","upperLimit":"17.8","value":"14.6"},{"groupId":"OG001","lowerLimit":"8.9","upperLimit":"14.6","value":"11.9"},{"groupId":"OG002","lowerLimit":"10.3","upperLimit":"12.8","value":"11.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"342"},{"groupId":"OG001","value":"346"},{"groupId":"OG002","value":"344"}],"units":"Participants"}],"description":"Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1).\n\nMedian PFS2 was calculated using the Kaplan-Meier technique.","dispersionType":"95% Confidence Interval","groups":[{"description":"MEDI4736 (Durvalumab) + Tremelimumab","id":"OG000","title":"Combination Therapy"},{"description":"MEDI4736 (Durvalumab)","id":"OG001","title":"Monotherapy"},{"description":"Standard of Care Chemotherapy Treatment","id":"OG002","title":"Standard of Care"}],"paramType":"MEDIAN","populationDescription":"Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.","reportingStatus":"POSTED","timeFrame":"Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).","title":"PFS2, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC","type":"SECONDARY","unitOfMeasure":"Months"}