{"analyses":[{"ciLowerLimit":"0.58","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"0.83","groupDescription":"Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \\[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\\] was presented.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.70","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"244","upperLimit":"278","value":"259.0"},{"groupId":"OG001","lowerLimit":"310","upperLimit":"363","value":"335.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"701"},{"groupId":"OG001","value":"699"}],"units":"Participants"}],"description":"PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Superiority analysis that followed 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. Superiority of the bevacizumab-containing arms was compared with the placebo-containing arms.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+P: Participants 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).\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).","id":"OG000","title":"FOLFOX-4+P/XELOX+P"},{"description":"Participants from the 2x2 factorial part of the study including the following groups -\n\n1. 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).\n2. 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":"FOLFOX-4+BV/XELOX+BV"}],"paramType":"MEDIAN","populationDescription":"The ITT population included all randomized participants who provided written informed consent.","reportingStatus":"POSTED","timeFrame":"Baseline until disease progression or death, approximately 2 years 6 months","title":"PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone","type":"SECONDARY","unitOfMeasure":"days"}