Table 4.

Exposure–safety analyses

Generic name	No. of patients	Exposure measure	Dose range	irAE	AESI	TEAE	AE (grade 3 or higher)	AE-D/DC	References
Ipilimumab	498	Cmin,ss	0.3–10 mg/kg	Positive relationship					[15]
Atezolizumab	513	AUC21, AUCss, Cmax, Cmin	1–20 mg/kg/1200 mg		No relationship		No relationship		[18]
	1007	AUCss	15 mg/kg/1200 mg		Positive relationship		Positive relationship		[19]
Avelumab	1629	AUCss, Ctrough,first, Ctrough,ss	1–20 mg/kg	Ctrough,ss: positive relationship		No relationship			[22]
Durvalumab	1393	Cmax,1, Cmin,2, Cmin,ss	10 mg/kg		No relationship		No relationship		[29]
Nivolumab	306	Dose	0.1–10.0 mg/kg				No relationship	No relationship	[33]
	336	Cavg1	0.1–10.0 mg/kg					No relationship	[34]
Pembrolizumab	544	AUCss–6 weeks	2–10 mg/kg	No relationship					[44]
		Dose	2–10 mg/kg	No relationship					[44]

AE adverse event, AE-D/DC adverse events leading to drug discontinuation or death, AESI adverse events of special interest, irAE immune-related adverse events, TEAE treatment-emergent adverse events, C_trough,ss trough concentration at steady state, C_min,ss minimum concentration at steady state, AUC₂₁ area under the concentration–time curve from time zero to 21 h, AUC_SS area under the concentration–time curve at steady state, C_max maximum concentration, C_min minimum concentration, C_trough,first trough plasma concentration after the first dose, C_max,1 maximum plasma concentration after the first dose, C_min,2 minimum plasma concentration after the second dose, C_avg1 time-averaged plasma concentration after the first dose