{"analyses":[{"ciLowerLimit":"0.72","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"0.95","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":"0.0015","paramType":"Hazard Ratio (HR)","paramValue":"0.83","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"230","upperLimit":"258","value":"245.0"},{"groupId":"OG001","lowerLimit":"276","upperLimit":"300","value":"287.0"}]}]}],"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 who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. 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 BV-containing arms was compared with the chemotherapy alone 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 by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone","type":"SECONDARY","unitOfMeasure":"days"}