{"analyses":[{"ciLowerLimit":"0.78","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.28","groupDescription":"Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX 4+P/XELOX+P) \\ 1.0. The test used a two-sided significance level of 2.5%","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.9887","paramType":"Odds Ratio (OR)","paramValue":"1.00","statisticalMethod":"Chi-squared","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37.5"},{"groupId":"OG001","value":"37.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"701"},{"groupId":"OG001","value":"699"}],"units":"Participants"}],"description":"According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.","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":"NUMBER","populationDescription":"The ITT population included all randomized participants who provided written informed consent.","reportingStatus":"POSTED","timeFrame":"From baseline until disease progression/recurrence, approximately 2 years 6 months","title":"BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone","type":"SECONDARY","unitOfMeasure":"Percentage of responders"}