Population Pharmacokinetics of Inotuzumab Ozogamicin in Pediatric Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia: Results of Study ITCC-059

Table 2 Summary of patient baseline covariates

Covariates, median [range]	Patients with adult B-cell NHL	Patients with adult BCP-ALL	Patients with pediatric BCP-ALL
Number of patients	531	234	53
Age, years	65.0 [18.0–92.0]	46.0 [20.0–79.0]	9.00 [1.00–17.0]
Body weight, kg	73.2 [33.5–148]	74.0 [30.9–154]	34.3 [12.7–147]
Body surface area^a, m²	1.83 [1.12–2.56]	1.86 [1.27–2.81]	1.18 [0.550–2.21]
Lean body mass^b, kg	53.6 [24.4–87.4]	54.4 [29.4–95.9]	29.5 [10.9–69.0]
Albumin, g/dL	4.00 [2.20–5.20]	3.80 [1.80–4.93]	3.60 [2.50–4.60]
Alanine aminotransferase, U/L	20.4 [3.00–236]	33.0 [5.00–161]	61.0 [4.00–187]
White blood cells in peripheral blood, × 10⁹ counts	NA	NA	3.33 [0.19–132]
Blasts in peripheral blood, %	NA	4.00 [0.00–100]	3.00 [0.00–85.0]
Absolute blast counts in peripheral blood, × 10⁹ counts	NA	0.82 [0.00–254]	0.00 [0.00–32.0]
Baseline NCI ODWG criteria for hepatic impairment (%)
A (normal)	444 (83.6)	167 (71.4)	31 (58.5)
B1 (mild)	75 (14.1)	58 (24.8)	20 (37.7)
B2 (mild)	9 (1.70)	8 (3.40)	2 (3.80)
C (moderate)	2 (0.40)	1 (0.40)	0
D (severe)	1 (0.20)	0	0
Unknown	0	0	0

BCP-ALL B-cell precursor acute lymphoblastic leukemia, NA non-applicable, NCI ODWG National Cancer Institute Organ Dysfunction Working Group, NHL non-Hodgkin lymphoma
^aBaseline body surface area calculated by the DuBois method for adults, estimated by the Mosteller formula for children
^bBaseline lean body mass (estimated by Boer’s equations for adults, and by the equation established by Peters et al. for children) [29, 30]