{"analyses":[{"groupDescription":"The two treatment groups were compared using a stratified log rank test with a one-sided alpha of 0.01 stratified by (3rd vs 4th-line; and geographical region). The null hypothesis that both treatment arms have the same PFS distribution was tested against the alternative hypothesis that the distribution of PFS in the regorafenib arm is different from the control arm according to a proportional hazards relation between the treatment arms.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.000001","statisticalComment":"stratified","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.185","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.388","estimateComment":"regorafenib over placebo","groupDescription":"Hazard ratio and its 95% CI (Confidence Interval) was based on stratified Cox Regression Model","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Hazard Ratio (HR)","paramValue":"0.268","statisticalComment":"stratified","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"122","upperLimit":"173","value":"147"},{"groupId":"OG001","lowerLimit":"28","upperLimit":"32","value":"28"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"66"}],"units":"Participants"}],"description":"Progression-free Survival (PFS) was defined as the time from date of randomization to radiological disease progression or death due to any cause, whichever occurs first. PFS was based on central radiological assessment using modified RECIST (Response Evaluation Criteria in Solid Tumors) v.1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks","id":"OG000","title":"Regorafenib (Stivarga, BAY73-4506)"},{"description":"Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"Full Analysis Set (FAS) - defined as all randomized participants.","reportingStatus":"POSTED","timeFrame":"From randomization of the first subject until approximately 144 progression-free survival events had occurred (study duration approximately one year)","title":"Progression-free Survival","type":"PRIMARY","unitOfMeasure":"Days"}