{"analyses":[{"ciLowerLimit":"0.47","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.80","estimateComment":"Reference level = Chemoradiation","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.6266","paramType":"Odds Ratio (OR)","paramValue":"0.92","statisticalComment":"Two-sided significance level = 0.05","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"55.4","upperLimit":"77.5","value":"67.1"},{"groupId":"OG001","lowerLimit":"52.1","upperLimit":"73.8","value":"63.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"82"}],"units":"Participants"}],"description":"Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. \"Treatment-related\" is defined definitely, probably, or possibly related to treatment.","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 who started protocol treatment","reportingStatus":"POSTED","timeFrame":"From start of treatment to last follow-up. Maximum follow-up at time of analysis was 47.2 months.","title":"Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events","type":"SECONDARY","unitOfMeasure":"percentage of participants"}