{"analyses":[{"ciLowerLimit":"0.09","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.39","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":"No formal statistical testing was done.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"Hazard Ratio (HR)","paramValue":"0.35","testedNonInferiority":true}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"196","upperLimit":"403","value":"347.0"},{"comment":"The estimate is Not Available due to insufficient follow-up time to estimate the missing parameter.","groupId":"OG001","lowerLimit":"270","upperLimit":"NA","value":"589.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"937"},{"groupId":"OG001","value":"967"}],"units":"Participants"}],"description":"For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. 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":"From baseline until disease progression/recurrence, approximately 2 years 6 months","title":"Duration of Complete Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4","type":"SECONDARY","unitOfMeasure":"days"}