Table 3.

Shift in AST (U/L) from baseline to maximum post‐baseline value while on study drug in BEACON

Treatment group/baseline AST	Maximum post‐baseline value while on treatment
	≤ULN	>ULN to < 3 × ULN	≥ 3 × ULN to < 5 × ULN	≥ 5 × ULN to < 8 × ULN	≥ 8 × ULN	No post‐baseline value
Placebo [n = 1,097]
AST ≤ ULN [n = 1096; %]	1,009 [92]	65 [6]	1 [< 1]	0	0	21 [2]
>ULN to < 3 × ULN [n = 1]	1 [< 1]	0	0	0	0	0
≥3 × ULN to < 5 × ULN [n = 0]	0	0	0	0	0	0
≥5 × ULN to < 8 × ULN [n = 0]	0	0	0	0	0	0
≥8 × ULN [n = 0]	0	0	0	0	0	0
Bardoxolone Methyl [n = 1088]
AST ≤ ULN [n = 1084; %]	709 [65]	292 [27]	11 [1]	3 [< 1]	2 [< 1]	67 [6]
>ULN to < 3 × ULN [n = 4]	0	2 [< 1]	1 [< 1]	1 [< 1]	0	0
≥3 × ULN to < 5 × ULN [n = 0]	0	0	0	0	0	0
≥5 × ULN to < 8 × ULN [n = 0]	0	0	0	0	0	0
≥8 × ULN [n = 0]	0	0	0	0	0	0

Post‐baseline laboratory assessments include those collected on or before a patient’s last dose of study drug. The upper limit for the population reference range (ULN) for AST is 37 (U/L). Categories listed in the tables are defined by AST (U/L) values: ≤ 37; > 37 to < 112; ≥ 112 to < 186; ≥ 186 to < 296; and ≥ 296. Denominators include the number of patients within each baseline laboratory assessment category and treatment group with usable assessments at both time points. Highlighted cells indicate no change.