{"analyses":[{"ciLowerLimit":"0.71","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.14","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":"0.3091","paramType":"Odds Ratio (OR)","paramValue":"0.90","statisticalMethod":"Chi-squared","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"49.2"},{"groupId":"OG001","value":"46.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"701"},{"groupId":"OG001","value":"699"}],"units":"Participants"}],"description":"According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of 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":"Best Overall Response (BOR) as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone","type":"SECONDARY","unitOfMeasure":"Percentage of responders"}