{"analyses":[{"ciLowerLimit":"0.97","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.20","groupDescription":"General approach: 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":"1.08","testedNonInferiority":true},{"ciLowerLimit":"0.98","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.23","groupDescription":"On-treatment Approach: 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":"Fewer events were expected in analyses using the on-treatment approach than in the analyses using the general approach, thus leading to reduced power.Therefore, no formal statistical testing was performed.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"Hazard Ratio (HR)","paramValue":"1.10","testedNonInferiority":true}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"183","upperLimit":"202","value":"191.0"},{"groupId":"OG001","lowerLimit":"171","upperLimit":"187","value":"179.0"}]}],"title":"General Approach"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"182","upperLimit":"200","value":"190.0"},{"groupId":"OG001","lowerLimit":"170","upperLimit":"185","value":"176.0"}]}],"title":"On-treatment Approach"}],"denoms":[{"counts":[{"groupId":"OG000","value":"990"},{"groupId":"OG001","value":"1008"}],"units":"Participants"}],"description":"Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase.The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.","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 safety population included all participants who were randomized and received 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":"Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4","type":"SECONDARY","unitOfMeasure":"days"}