Table 4.

Logistic regression analysis for adverse events

Parameter	Estimate	SE	RSE (%)	95% CI	p value
Grade ≥ 3 neutropenia
Intercept	− 0.20	0.44	223.9	− 1.07; 0.67	0.66
Slope of AUCss nominal (μg × day/mL)	1.76	0.76	42.9	0.28; 3.25*	0.325
Grade ≥ 3 infection
Intercept	− 3.65	1.06	29.07	− 5.73; − 1.57	0.00058
Slope of AUCss nominal (μg × day/mL)	− 0.20	0.72	353.88	− 1.62; 1.21*	0.874
Age	0.04	0.02	36.89	0.01; 0.07	0.0067
Grade ≥ 3 febrile neutropenia
Intercept	− 0.81	0.42	51.53	− 1.63; 0.01	0.052
Slope of AUCss nominal (μg × day/mL)	− 0.46	0.66	144.05	− 1.75; 0.84*	0.0608
IPI (high) [4, 5]a	1.20	0.33	27.36	0.55; 1.84	0.00026
Grade ≥ 3 thrombocytopenia
Intercept	− 8.70	1.59	18.33	− 11.82; − 5.57	0.000000049
Slope of AUCss nominal (μg × day/mL)	0.59	0.75	127.03	− 0.88; 2.05*	0.521
Age	0.11	0.02	20.66	0.06; 0.15	0.0000013
ECOG (2+)b	1.65	0.45	27.62	0.75; 2.54	0.00029
Serious adverse events
Intercept	− 3.07	0.87	28.36	− 4.77; − 1.36	0.00042
Slope of AUCss nominal (μg × day/mL)	− 0.51	0.63	123.64	− 1.75; 0.73*	0.628
Age	0.05	0.01	25.93	0.02; 0.07	0.00011

95% CI 95% confidence interval on the parameter estimate, AUC_ss venetoclax individual predicted area under the curve at steady state based on the cohort-assigned dose, RSE relative standard error of the parameter estimate (%), SE standard error

*95% CI of the exposure parameter spans zero, indicating statistical nonsignificance

^aIPI (high) [4, 5] represents patients with IPI scores of 4 and 5 and in the covariate analysis were compared with those with the IPI scores of 0, 1, and 2

^bECOG (2+) represents patients with ECOG PS score ≥ 2 and in the covariate analysis were compared with those with ECOG PS score < 2

*95% CI of the exposure parameter spans zero, indicating statistical nonsignficance