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