Table 5.
Number (%) of Participants with Treatment‐Emergent Adverse Events
| Normal Renal Function | Renal Impairment | End‐Stage Renal Disease (Group 5) | ||||
|---|---|---|---|---|---|---|
| Adverse Event | Group 1 Normal (n = 6) | Group 2 Mild (n = 6) | Group 3 Moderate (n = 6) | Group 4 Severe (n = 6) | Group 5.1 Without Hemodialysisa (n = 6) | Group 5.2 With Hemodialysis (n = 7) |
| Any TEAE | 0 | 1 (17%) | 1 (17%) | 0 | 1 (17%) | 1 (14%) |
| Nausea | 0 | 0 | 0 | 0 | 1 (17%) | 0 |
| Skin abrasion | 0 | 1 (17%) | 0 | 0 | 0 | 0 |
| ALT increased | 0 | 0 | 0 | 0 | 0 | 1 (14%) |
| AST increased | 0 | 0 | 0 | 0 | 0 | 1 (14%) |
| Headache | 0 | 0 | 1 (17%) | 0 | 0 | 0 |
ALT indicates alanine aminotransferase; AST, aspartate aminotransferase; TEAE, treatment‐emergent adverse event.
a
One participant from Group 5 discontinued the study before day 8 due to adverse events of mild elevated ALT and AST.