{"analyses":[{"ciLowerLimit":"0.84","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.14","groupDescription":"HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).","groupIds":["OG000","OG001"],"nonInferiorityComment":"This study was not powered for testing non-inferiority of XELOX vs FOLFOX-4 with respect to overall survival and no margin could be derived following the effect retention concept. The same margins used for the PFS analysis \\[Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin)\\] were therefore applied to OS as well.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"Hazard Ratio (HR)","paramValue":"0.97","testedNonInferiority":true}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"528","upperLimit":"576","value":"549.0"},{"groupId":"OG001","lowerLimit":"535","upperLimit":"615","value":"577.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"937"},{"groupId":"OG001","value":"967"}],"units":"Participants"}],"description":"Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).\n2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).","id":"OG000","title":"FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV"},{"description":"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).\n3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).","id":"OG001","title":"XELOX/XELOX+P/XELOX+BV"}],"paramType":"MEDIAN","populationDescription":"The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.","reportingStatus":"POSTED","timeFrame":"Baseline until disease progression or death, approximately 2 years 6 months","title":"Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4","type":"SECONDARY","unitOfMeasure":"days"}