{"analyses":[{"groupDescription":"CmaxSS for Gr Dermatological toxicity for Exposure-Response Analyses.","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.265","statisticalMethod":"Wald test"},{"groupDescription":"CmaxSS for Gr3+ Dermatological Toxicity for Exposure-Response Analyses.","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.0159","statisticalMethod":"Wald test"},{"groupDescription":"CmaxSS for Gr Proteinuria for Exposure-Response Analyses.","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.484","statisticalMethod":"Wald test"},{"groupDescription":"CmaxSS for Gr3+ Proteinuria for Exposure-Response Analyses.","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.642","statisticalMethod":"Wald test"},{"groupDescription":"CmaxSS for Gr Hemorrhage for Exposure-Response Analyses.","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.166","statisticalMethod":"Wald test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.00134"}]}],"title":"CmaxSS Coefficient for Gr Dermatological toxicity for Exposure-Response Analyses"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.00411"}]}],"title":"CmaxSS Coefficient for Gr3+ Dermatological Toxicity for Exposure-Response Analyses"},{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.00101"}]}],"title":"CmaxSS Coefficient for Gr Proteinuria for Exposure-Response Analyses"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.00143"}]}],"title":"CmaxSS Coefficient for Gr3+ Proteinuria for Exposure-Response Analyses"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.00180"}]}],"title":"CmaxSS Coefficient for Gr Hemorrhage for Exposure-Response Analyses"}],"denoms":[{"counts":[{"groupId":"OG000","value":"515"}],"units":"Participants"}],"description":"Model-predicted steady-state maximum plasma concentration (CmaxSS) of fruquintinib based on the assigned dose of fruquintinib were investigated as fruquintinib exposure measure for the safety exposure-response analyses. The correlation between exposure and the probability of experiencing these AEs was evaluated using logistic regression analysis, with the slope serving as the estimate. The safety exposure-response analysis included participants with cancer, and the data of this outcome measure were pooled with data from the following studies as per the planned analysis: 2019-013-GLOB1 (NCT04322539) (N=334), 2009-013-00CH1 (NCT01645215) (N=40), 2012-013-00CH3 (NCT01975077) (N=40), and 2015-013-00US1 (NCT03251378) (N=101). Here, the \"unit of measure\" i.e., '1/(ng/mL)', corresponds to the coefficient that describes the relationship between the probability of occurrence of the safety parameter and CmaxSS value.","groups":[{"description":"Participants in the current 2019-013-GLOB1 (NCT04322539) study received 5 mg of fruquintinib oral capsules once daily for 3 weeks of continuous dosing, followed by a 1-week break during each 28-day treatment cycle. Participants in the 2009-013-00CH1 (NCT01645215) study received 1 mg to 6 mg of fruquintinib oral capsule once daily and 5 mg to 6 mg of fruquintinib oral capsule for 3 weeks on and 1 week off during each 28-day treatment cycle. Participants in the 2012-013-00CH3 (NCT01975077) study received 4 mg of fruquintinib capsule once daily in 28-day cycles. Participants in the Study 2015-013-00US1 (NCT03251378) with advanced solid tumors of any type or with mCRC received fruquintinib 3 mg or 5 mg 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 Safety Analysis"}],"paramType":"NUMBER","populationDescription":"Safety exposure-response analyses included participants who were evaluable for population PK analysis and therefore had PK parameter estimates to enable estimation of fruquintinib exposure and evaluated for 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 2019-013-GLOB1, 2009-013-00CH1, 2012-013-00CH3, and 2015-013-00US1.","reportingStatus":"POSTED","timeFrame":"Up to 22 months","title":"Correlation Between Fruquintinib Exposure (CmaxSS) and Safety Parameters (Any Grade [Gr] and Grade 3+ (Gr3+): Dermatological Toxicity, Proteinuria and Gr Hemorrhage)","type":"SECONDARY","unitOfMeasure":"1/(ng/mL)"}