Dataset construction and preliminary analyses
EVENT
Individual average cabozantinib concentrations from time zero to the event or censoring time (CAVG0T) were calculated from the estimated individual PK parameters of the final PopPK model and individual dosing history; CAVG0T was used for the exposure–response analysis dataset to link clinical endpoints with individual predicted cabozantinib exposure.The average cabozantinib concentration, CAVG0T, in units of ng/mL was defined as (Eq. Kaplan–Meier (KM) plots were constructed for each efficacy and safety endpoint prior to model development. Patients were grouped into quartiles based on CAVG0T or apparent clearance for corresponding clinical endpoints. The preliminary analyses were performed to identify potential relationships between cabozantinib exposure and each clinical endpoint. Only time to the first event was considered for the analyses of safety endpoints.