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. Author manuscript; available in PMC: 2023 Jul 1.
Published in final edited form as: Pediatr Infect Dis J. 2022 Jun 7;41(7):556–562. doi: 10.1097/INF.0000000000003559

Table 3:

Summary of Liver Function Tests by Treatment Arm - Safety Population

Solithromycin
N=70
Comparator
N=24
Outcome Screening
n/N (%)
Follow-Up
n/N (%)
Screening
n/N (%)
Follow-Up
n/N (%)
ALT > ULN 3 (4.6%) 11 (16.4%) 1 (4.3%) 3 (13.6%)
> 3x ULN 0 1 (1.5%) 0 0
> 10x ULN 0 0 0 0
Evaluable subjects 65 67 23 22
AST > ULN 11 (16.9%) 13 (19.4%) 3 (13.0%) 4 (18.2%)
> 3x ULN 1 (1.5%) 1 (1.5%) 0 0
> 10x ULN 0 0 0 0
Evaluable subjects 65 67 23 22
ALT or AST > ULN 12 (18.5%) 18 (26.9%) 4 (17.4%) 6 (27.3%)
> 3x ULN 1 (1.5%) 2 (3.0%) 0 0
> 10x ULN 0 0 0 0
Evaluable subjects 65 67 23 22
Direct bilirubin > ULN 1 (1.7%) 3 (4.5%) 0 1 (4.3%)
> 3x ULN 0 0 0 0
> 10x ULN 0 0 0 0
Evaluable subjects 60 67 20 23

AST – aspartate aminotransferase, ALT – alanine aminotransferase, ULN – upper limits of normal