{"analyses":[{"ciLowerLimit":"0.267","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.386","estimateComment":"The HR between the 2 treatment groups (fruquintinib vs placebo), together with its 95% CI, was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< .001","pValueComment":"Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.","paramType":"Hazard Ratio (HR)","paramValue":"0.321","statisticalMethod":"stratified log-rank test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.5","upperLimit":"3.8","value":"3.7"},{"groupId":"OG001","lowerLimit":"1.8","upperLimit":"1.9","value":"1.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"461"},{"groupId":"OG001","value":"230"}],"units":"Participants"}],"description":"PFS was defined as the time (months) from randomization until the first radiographic documentation of objective progression as assessed by investigator using RECIST v1.1, or death from any cause, whichever comes first. More specifically, PFS was determined using all data until the last evaluable visit prior to or on the date of: (i) radiographic disease progression (PD) per RECIST v1.1; (ii) withdrawal of consent to obtain additional scans on study; or (iii) initiation of subsequent anticancer therapy other than the study drugs, whichever was earlier. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).","id":"OG000","title":"Fruquintinib + BSC Group"},{"description":"Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).","id":"OG001","title":"Placebo + BSC Group"}],"paramType":"MEDIAN","populationDescription":"ITT population included all randomized participants.","reportingStatus":"POSTED","timeFrame":"From randomization until the first documentation of objective progression or death, whichever comes first (up to 22 months)","title":"Progression Free Survival (PFS), as Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1","type":"SECONDARY","unitOfMeasure":"months"}