Table 1.

Covariates considered in the pharmacokinetic and pharmacokinetic–pharmacodynamic analysis

Analysis	Parameters	Covariates
PK	CL/F	Baseline body weight or BSA, sex (male or female), race (Asian or non-Asian), baseline ECOG PS (0 or ≥ 0), age
PK	Vc/F	Baseline body weight, BSA, sex (male or female), age
PK	ka	Formulation (intact capsule or sprinkle capsule contents on yogurt or apple sauce)
PK–PD	EC50	Baseline body weight or BSA, sex (male or female), baseline ECOG PS (0 or ≥ 0), age, baseline PD value
PD–PD	kPD	Baseline body weight or BSA, sex (male or female), baseline ECOG PS (0 or ≥ 0), age, baseline PD value

BSA baseline surface area, CL/F apparent clearance, EC₅₀ concentration at half maximum effect, ECOG PS Eastern Cooperative Oncology group performance status, k_a first-order absorption rate constant, k_PD effect first-order rate constant, PD pharmacodynamic, PK pharmacokinetic, Vc/F apparent central volume of distribution