{"analyses":[{"ciLowerLimit":"0.76","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.16","groupDescription":"Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \\ 0.66","groupIds":["OG000","OG001"],"nonInferiorityComment":"The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab shall be concluded if the lower limit of this confidence interval is above 0.66.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"Odds Ratio (OR)","paramValue":"0.94","testedNonInferiority":true}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38.6"},{"groupId":"OG001","value":"37.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"937"},{"groupId":"OG001","value":"967"}],"units":"Participants"}],"description":"According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.","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":"NUMBER","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":"From baseline until disease progression/recurrence, approximately 2 years 6 months","title":"BOR as Assessed by the IRC According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4","type":"SECONDARY","unitOfMeasure":"Percentage of responders"}