TABLE 7.
Number (%) of subjects in arms A and B displaying elevations in ALT and AST above the ULN due to any causea
| ×ULN by levels | Arm A |
Arm B |
||
|---|---|---|---|---|
| First dosing | Redosing | First dosing | Redosing | |
| n | 24 | 18 | 30 | 19 |
| ALT | ||||
| 1–3 | 10 (42) | 5 (28) | 11 (37) | 5 (26) |
| 3–5 | 2 (11) | 1 (3) | ||
| 5–10 | 1 (4) | 1 (6) | 3 (10) | 2 (11) |
| 10–20 | 1 (5) | |||
| >20 | 1 (3) | |||
| AST | ||||
| 1–3 | 5 (21) | 4 (22) | 12 (40) | 4 (21) |
| 3–5 | 2 (11) | 2 (7) | ||
| 5–10 | 1 (4) | 1 (6) | 2 (11) | |
| 10–20 | 1 (3) | 1 (5) | ||
| >20 | ||||
a
The percentages are based on the number of subjects actually administered at least one dose of PA during a given dosing period.