{"analyses":[{"ciLowerLimit":"0.52","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"0.75","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":"0.63","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"227","upperLimit":"254","value":"241.0"},{"groupId":"OG001","lowerLimit":"294","upperLimit":"338","value":"316.0"}]}]}],"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. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-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 (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone","type":"SECONDARY","unitOfMeasure":"days"}