Table 4.

Shift in ALT from maximum post‐baseline value while on study drug to post‐treatment visit assessment

Treatment group/Maximum post‐baseline ALT	Post‐treatment visit value
	≤ ULN	>ULN to < 3 × ULN	≥3 × ULN to < 5 × ULN	≥5 × ULN to < 8 × ULN	≥8 × ULN	No Post‐Treatment Value
Placebo [n = 1097]
No Post‐Baseline Value [n = 20]	0	0	0	0	0	20 [2]
ALT ≤ ULN [n = 1023]	841 [77]	6	0	1 [<1]	0	175 [16]
>ULN to < 3 × ULN [n = 51]	34 [3]	4 [<1]	0	0	0	13 [1]
≥3 × ULN to < 5 × ULN [n = 2]	2 [<1]	0	0	0	0	0
≥5 × ULN to < 8 × ULN [n = 1]	0	0	0	0	0	1 [<1]
≥8 × ULN [n = 0]	0	0	0	0	0	0
Bardoxolone Methyl [n = 1088]
No Post‐Baseline Value [n = 67]	0	0	0	0	0	67 [6]
ALT ≤ ULN [n = 610]	483 [44]	5 [<1]	0	0	0	122 [11]
>ULN to < 3 × ULN [n = 380]	290 [27]	20 [2]	0	0	0	70 [6]
≥3 × ULN to < 5 × ULN [n = 19]	12 [1]	1 [<1]	0	0	0	6 [1]
≥5 × ULN to < 8 × ULN [n = 10]	8 [<1]	1 [<1]	0	0	0	1 [<1]
≥8 × ULN [n = 2]	2 [<1]	0	0	0	0	0

Includes only patients randomized to bardoxolone methyl or placebo with post‐baseline and post‐treatment ALT values. Post treatment values are defined as ALT assessments collected closest to 28 days [but ≥ 14 days and ≤ 84 days] after a patient’s last dose of study drug. The upper limit of the population reference range [ULN] for ALT is 47 [U/L]. Categories listed in the tables are defined by ALT [U/L] values: ≤47; >47 to < 142; ≥142 to < 236; ≥236 to < 376; ≥376. Denominators include the number of patients within each worst post‐baseline laboratory assessment category and treatment group with usable assessments at both time points. Highlighted cells indicate no change.

ALT, alanine aminotransferase; BEACON, Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes; U/L, units per liter; ULN, upper limit of normal.