Table 2.

Summary of exposure–response modeling for safety in the IPATential150 study

Parameter	Adverse event
	SAE	Dsc	DRd	Hgl2	Dr2	Dr3	Rsh2
Ipatasertib: 400 mg			11.2*		8.62*	16.3*	25.5*
AUCss (per 1000 ng h/mL)	1.22*	1.37*		1.67*	1.12
Baseline age (per 10 years)	1.24*	1.25	1.41*		1.3*
Baseline weight (per 10 kg)	0.901*	0.867*	1.13*	1.11			0.808*
Race: Asian	0.656*				0.51*	0.429	1.43
Race: American Indian/Alaska Native							0.365
Region: Asia–Pacific			1.67*
Region: USA			1.67*
Region: Rest of World		0.522	2.34*	1.98*	2.27*	2.45*
Baseline ECOG: ≥ 1	1.35
Prior taxane-based therapy		0.665				0.307*
Visceral metastasis				0.593			0.556*
Progression factor		1.34	0.713*
Baseline glucose (per 1 mmol/L)				1.77*
Baseline HbA1c (per 5%)				1.63*

Numbers are odds ratios provided by AIC reduced models. *p < 0.05

SAE serious adverse event, Dsc adverse event leading to discontinuation, DRd adverse event leading to dose reduction, Hgl2 hyperglycemia (Grade ≥ 2), Dr2 diarrhea (Grade ≥ 2), Dr3 diarrhea (Grade ≥ 3), Rsh2 rash (Grade ≥ 2)