Table 4.
Treatment‐Emergent Adverse Events
Renal Classification According to CrCl | ||||||
---|---|---|---|---|---|---|
Normal (n = 6) | Mild (n = 6) | Moderate (n = 6) | Severe (n = 6) | ESRDa (n = 6) | Total (n = 6) | |
Subjects with any TEAE, n (%) | 2 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (66.7) | 6 (20) |
Decreased appetite | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.3) |
Hyperkalemia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 1 (3.3) |
Dizziness | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (50.5) | 3 (10.0) |
Somnolence | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 2 (6.7) |
Headache | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.3) |
Vomiting | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 2 (6.7) |
Constipation | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.3) |
CrCl, creatinine clearance; ESRD, end‐stage renal disease; TEAE, treatment‐emergent adverse event.
4‐hour hemodialysis 24 hours after drug administration.