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. 2025 Oct 3;52(5):55. doi: 10.1007/s10928-025-10003-w

Table 2.

Final model parameter estimates for OAEs (fixed effects)

Estimate 95% CI
Structural model parameters
Inline graphic exp(θ1)/(1 + exp(θ1)) Probability of transition to grade ≥ 2 event from grade ≤ 1 0.000209 0.000107–0.000408
Inline graphic exp(θ2)/(1 + exp(θ2)) Probability of staying in state 2+ from grade ≥ 2 0.963 0.950–0.972
Inline graphic θ3 Emax for ADCe 11.7 5.45–17.9
Inline graphic exp(θ5) ADC effect compartment rate constant 0.0389 0.0313–0.0484
ζ11 θ6 Nonproportionality adjustment for ADCe in event state 0.215 0.112–0.318
Inline graphic θ7 Hill parameter for ADCe 1.00 FIXED
Inline graphic θ18 EC50 for ADCe 4.91 0.158–9.66
Covariate effect parameters
γ1 θ9 ADCe-modifying effect of bevacizumab 1.25 0.901–1.59
γ2 θ11 ADCe-modifying effect of carboplatin 0.920 0.710–1.13
γ3 θ12 ADCe-modifying effect of pembrolizumab 1.07 0.887–1.25
γ4 θ13 ADCe-modifying effect of baseline ocular conditions 0.887 0.518–1.26
γ5 θ14 ADCe-modifying effect of dry eyes at baseline 1.36 0.747–1.97
γ6 θ20 ADCe-modifying effect of ECP 0.685 0.581–0.789

Final model:

Inline graphic

and

Inline graphic

Parameters estimated in the log-domain were back-transformed for clarity. CIs = estimate ± 1.96 · SE

ADC antibody–drug conjugate, ADCe antibody–drug conjugate through an effect compartment; EC50, half maximal effective concentration; ECP, eye care plan; Emax, maximum effect; OAE, ocular adverse event; SE, standard error