{"analyses":[{"ciLowerLimit":"0.77","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.73","estimateComment":"Reference level = Chemoradiation","groupDescription":"The study was powered to detect an improvement of the 1-year progression-free survival rate from 50% (no metformin) to 65% (metformin) or equivalently a hazard ratio (HR) of 0.622, at one-sided type 1 error of 0.1 and 85% power with at least 102 progression-free survival events.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7563","paramType":"Hazard Ratio (HR)","paramValue":"1.15","statisticalComment":"One-sided significance level = 0.10","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"48.5","upperLimit":"70.4","value":"60.4"},{"groupId":"OG001","lowerLimit":"39.8","upperLimit":"61.7","value":"51.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"86"}],"units":"Participants"}],"description":"Progression is defined per RECIST v1.1 as change in a known lesion(s) meeting one of the following criteria: \\[1\\] At least a 20% increase in the sum of the longest diameter of target lesions such that the absolute increase must be \\> 5 mm. \\[2\\] Appearance of ≥1 new lesions. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported.","dispersionType":"95% Confidence Interval","groups":[{"description":"60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin","id":"OG000","title":"Chemoradiation"},{"description":"Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin","id":"OG001","title":"Metformin + Chemoradiation"}],"paramType":"NUMBER","populationDescription":"Eligible participants","reportingStatus":"POSTED","timeFrame":"From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.","title":"Percentage of Participants Alive Without Progression (Progression-free Survival)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}