Table 4.
Number of Subjects (%) | ||||||
---|---|---|---|---|---|---|
Normal Renal Function | Moderate RI | |||||
CSL112 2 g | CSL112 6 g | Placebo | CSL112 2 g | CSL112 6 g | Placebo | |
(n = 6) | (n = 6) | (n = 4) | (n = 6) | (n = 6) | (n = 4) | |
Any TEAE | 3 (50.0) | 5 (83.3) | 2 (50.0) | 1 (16.7) | 3 (50.0) | 0 |
Blood bilirubin increased | 0 | 0 | 0 | 0 | 2 (33.3) | 0 |
Headache | 0 | 2 (33.3) | 1 (25.0) | 0 | 0 | 0 |
Serious AE | 0 | 2 (33.3) | 0 | 0 | 0 | 0 |
Procedure‐related AEs | 1 (16.7) | 2 (33.3) | 1 (25.0) | 1 (16.7) | 0 | 0 |
Treatment‐related AEs | 0 | 2 (33.3) | 1 (25.0) | 1 (16.7) | 3 (50.0) | 0 |
AE, adverse event; RI, renal impairment; TEAE, treatment‐emergent adverse event.