. 2023 Jul 9;23(3):221–237. doi: 10.1007/s40268-023-00427-5

Table 3.

Participants with treatment-emergent laboratory abnormalities relating to ALT, AST, bilirubin, and INR

Laboratory variable	Placebo n = 31 (100%)	BAY1128688					Total N = 121 (100%)
	Placebo n = 31 (100%)	3 mg OD n = 11 (100%)	10 mg OD n = 31 (100%)	30 mg OD n = 10 (100%)	30 mg BID n = 11 (100%)	60 mg BID n = 27 (100%)	Total N = 121 (100%)
ALT, U/L; n (%)^a
Total number of participants with > 2 × ULN	0	0	1 (3.2)	3 (30.0)	0	6 (22.2)	10 (8.3)
> 2 × ULN and ≤3 × ULN^b	0	0	1 (3.2)	0	0	1 (3.7)	2 (1.7)
> 3 × ULN and ≤5 × ULN^b	0	0	0	2 (20.0)	0	3 (11.1)	5 (4.1)
> 5 × ULN and ≤8 × ULN^b	0	0	0	0	0	1 (3.7)	1 (0.8)
> 8 × ULN^b	0	0	0	1 (10.0)	0	1 (3.7)	2 (1.7)
AST, U/L; n (%)^a
Total number of participants with > 2 × ULN	0	0	0	1 (10.0)	0	3 (11.1)	4 (3.3)
> 3 × ULN and ≤5 × ULN^b	0	0	0	0	0	2 (7.4)	2 (1.7)
> 8 × ULN^b	0	0	0	1 (10.0)	0	1 (3.7)	2 (1.7)
Bilirubin in serum, mg/dL; n (%)^a
> 2 × ULN	0	0	0	1 (10.0)	0	2 (7.4)	3 (2.5)

ALT alanine aminotransferase, AST aspartate aminotransferase, BID twice daily, INR international normalized ratio, OD once daily, ULN upper limit of normal

^aPercentages refer to the total sample size per treatment group (i.e., n)

^bOnly the largest value per participant was considered, such that a participant was only counted once, in the highest category. All individuals with AST > 2 × ULN were also observed to have ALT > 2 × ULN. The case of bilirubin > 2 × ULN in the 30 mg OD group refers to the participant described as ‘case 1’ (see Section 3.3) and was found to also have > 2 × ULN for ALT and AST. In contrast, the two participants in the 60 mg BID group with bilirubin > 2 × ULN demonstrated isolated increases of bilirubin only (i.e., no increase in ALT or AST)