{"analyses":[{"ciLowerLimit":"0.95","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.69","estimateComment":"OR, 95% CI and p-value were obtained from the Cochran-Mantel-Haenszel test adjusting by baseline ECOG performance status, region and liver metastases as per IWRS.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.11","paramType":"Odds Ratio (OR)","paramValue":"1.26","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"36.8","upperLimit":"46.9","value":"41.8"},{"groupId":"OG001","lowerLimit":"31.4","upperLimit":"41.2","value":"36.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"383"},{"groupId":"OG001","value":"387"}],"units":"Participants"}],"description":"The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) per RECIST Version 1.1. BOR was defined as the best response as recorded from randomization until documented objective disease progression using RECIST Version 1.1. As per RECIST version 1.1, CR is disappearance of all target lesions; PR is \\>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. The ORR was calculated using Clopper-Pearson method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were treated with irinotecan liposome injection 50 mg/m\\^2 followed by oxaliplatin 60 mg/m\\^2, followed by LV 400 mg/m\\^2 and then 5-FU 2400 mg/m\\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.","id":"OG000","title":"NALIRIFOX"},{"description":"Participants were treated with nab-paclitaxel 125 mg/m\\^2 followed by gemcitabine 1000 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.","id":"OG001","title":"Nab-paclitaxel+Gemcitabine"}],"paramType":"NUMBER","populationDescription":"The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization.","reportingStatus":"POSTED","timeFrame":"Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022, (maximum of 893 days)","title":"Overall Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}