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. 2018 Sep 21;8(5):628–636. doi: 10.1002/cpdd.618

Table 4.

Summary of Adverse Events by Renal Function and Treatment Groups

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.