Table 5.

Patients with elevated liver enzymes and TBL

Category, n (%)	Pexidartinib (N = 40)
Baseline AST ≥ ULN	0
Baseline ALT ≥ ULN	0
Baseline ALP ≥ ULN	0
Baseline TBL ≥ ULN	1 (2.5)
Postbaseline AST ≥ 3 × ULN	14 (35.0)
Postbaseline ALT ≥ 3 × ULN	15 (37.5)
Postbaseline AST ≥ 3 × ULN or ALT ≥ 3 × ULN	16 (40.0)
Postbaseline AST ≥ 5 × ULN	6 (15.0)
Postbaseline ALT ≥ 5 × ULN	8 (20.0)
Postbaseline AST ≥ 5 × ULN or ALT ≥ 5 × ULN	9 (22.5)
Postbaseline ALP ≥ 2.5 × ULN	3 (7.5)
Postbaseline TBL ≥ 2 × ULN	2 (5.0)
Concurrent TBL ≥ 2 × ULN with AST ≥ 3 × ULN	2 (5.0)
Concurrent TBL ≥ 2 × ULN with ALT ≥ 3 × ULN	2 (5.0)
Concurrent TBL ≥ 2 × ULN with AST ≥ 3 × ULN or ALT ≥ 3 × ULN	2 (5.0)

Baseline values were defined as the last nonmissing value before the first dose of the study drug. Concurrent was defined as ≥ 1 case of postdose TBL ≥ 2 × ULN that occurred between the first incidence date and 30 days after the last incidence date of the corresponding liver enzyme(s) ≥ 3 × ULN

ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; TBL, total bilirubin; ULN, upper limit of normal