{"analyses":[{"groupDescription":"CminSS Based on the Starting Dose for OS Exposure-Response Analyses","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.0600","statisticalMethod":"Wald test"},{"groupDescription":"CminSS Based on the Adjusted RDI for OS Exposure-Response Analyses","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.8065","statisticalMethod":"Wald test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.00193"}]}],"title":"CminSS Coefficient Based on the Starting Dose for OS Exposure-Response Analyses"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.000407"}]}],"title":"CminSS Coefficient Based on the Adjusted RDI for OS Exposure-Response Analyses"}],"denoms":[{"counts":[{"groupId":"OG000","value":"368"}],"units":"Participants"}],"description":"Model-predicted steady-state minimum plasma concentrations (CminSS) of fruquintinib based on the starting dose or adjusted for relative dose intensity \\[RDI\\] were used as the exposure measures in the efficacy exposure-response analyses. The correlation between OS and exposure was estimated using multivariable Cox proportional hazards modeling. OS was analyzed as time-to-event variable using a survival model. The efficacy exposure-response analyses included participants with mCRC and pooled the data from the fruquintinib group of current Study 2019-013-GLOB1 (N=328) and from Cohort B of Study 2015-013-00US1 (NCT03251378) (N=40) as per planned analysis. Here, the \"unit of measure\" i.e., '1/(nanogram per milliliter \\[ng/mL\\])', corresponds to the coefficient that describes the relationship between the probability of survival and CminSS value.","groups":[{"description":"Participants in the current 2019-013-GLOB1 (NCT04322539) study received 5 mg of fruquintinib oral capsules with BSC once daily for 3 weeks of continuous dosing, followed by a 1-week break during each 28-day treatment cycle. Participants in Cohort B of Study 2015-013-00US1 (NCT03251378) with metastatic colorectal carcinoma (mCRC) and treatment with chemotherapy and trifluridine, tipiracil, and/or regorafenib received fruquintinib 5 mg capsules, once daily, for 3 weeks on and 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by the Investigator, whichever occurred first.","id":"OG000","title":"Fruquintinib: Pooled Studies for Exposure and Efficacy Analysis"}],"paramType":"NUMBER","populationDescription":"The efficacy exposure-response analyses included participants who were evaluable for the population PK analysis and therefore had PK parameter estimates to enable estimation of fruquintinib exposure and evaluated for the parameter/endpoint in question. Here, \"overall number of participants analyzed\" signified those participants who were evaluable for this outcome measure. The population for this measure included participants from both studies 2015-013-00US1 and the current study.","reportingStatus":"POSTED","timeFrame":"Up to 22 months","title":"Correlation Between Fruquintinib Exposure (CminSS) and Efficacy Parameters (OS)","type":"SECONDARY","unitOfMeasure":"1/(ng/mL)"}