Table 3.

Comparison of regression models for QTc absolute values and ΔQTc vs avelumab concentration including (full model; Models 1 and 3) or not including (reduced model; Models 2 and 4) a parameter for diphenhydramine premedication

Parameter	Model	Variable	Coefficient ± SE	P value	90% CI
QTcP	1	Serum concentration slope, ms/(μg/mL)	0.002 ± 0.003	0.512	− 0.003–0.007
		Premedication intercept (ms)	3.935 ± 0.935	< 0.001	2.395–5.475
	2	Serum concentration slope, ms/(μg/mL)	0.011 ± 0.002	< 0.001	0.008–0.015
QTcF	1	Serum concentration slope, ms/(μg/mL)	0.003 ± 0.003	0.310	− 0.002–0.009
		Premedication intercept (ms)	4.227 ± 0.993	< 0.001	2.592–5.861
	2	Serum concentration slope, ms/(μg/mL)	0.014 ± 0.002	< 0.001	0.010–0.018
ΔQTcP	3	Serum concentration slope, ms/(μg/mL)	0.003 ± 0.003	0.266	− 0.002–0.009
		Premedication intercept (ms)	3.363 ± 0.918	< 0.001	1.851–4.874
	4	Serum concentration slope, ms/(μg/mL)	0.012 ± 0.002	< 0.001	0.008–0.015
ΔQTcF	3	Serum concentration slope, ms/(μg/mL)	0.005 ± 0.003	0.123	0.000–0.010
		Premedication intercept (ms)	3.610 ± 0.968	< 0.001	2.017–5.204
	4	Serum concentration slope, ms/(μg/mL)	0.014 ± 0.002	< 0.001	0.010–0.018

AIC Akaike information criterion, BIC Bayesian information criterion, QTcF QTc derived from Fridericia’s formula, QTcP QTc derived from a project-specific formula

QTcP: AIC(full model) – AIC(reduced model) = − 19.2; ([BIC(full model) − BIC(reduced model)]/2) = − 9.6

QTcF: AIC(full model) − AIC(reduced model) = − 19.8; ([BIC(full model) − BIC(reduced model)]/2) = – 9.9

ΔQTcP: AIC(full model) − AIC(reduced model) = − 14.8; ([BIC(full model) − BIC(reduced model)]/2) = − 7.4

ΔQTcF: AIC(full model) − AIC(reduced model) = − 15.5; ([BIC(full model) − BIC(reduced model)]/2) = − 7.7