Table 4.
Summary of AEs and ADRs.
| Parameter | All Participants | Baseline eGFR Category | Hemodialysis | |||
|---|---|---|---|---|---|---|
| G1 | G2 | G3a–G3b | G4–G5 | |||
| n | 189 | 21 | 123 | 34 | 8 | 3 |
| AE | ||||||
| Total | 155 (82.0) | 17 (81.0) | 97 (78.9) | 31 (91.2) | 7 (87.5) | 3 (100) |
| Serious | 16 (8.5) | 2 (9.5) | 4 (3.3) | 5 (14.7) | 2 (25.0) | 3 (100) |
| Leading to withdrawal | 11 (5.8) | 2 (9.5) | 3 (2.4) | 3 (8.8) | 3 (37.5) | 0 |
| ADR | ||||||
| Total | 60 (31.7) | 9 (42.9) | 34 (27.6) | 15 (44.1) | 2 (25.0) | 0 |
| Serious | 1 (0.5) | 0 | 1 (0.8) | 0 | 0 | 0 |
| Leading to withdrawal | 7 (3.7) | 2 (9.5) | 2 (1.6) | 1 (2.9) | 2 (25.0) | 0 |
| CK > ULN × 2.5 | 11 (5.8) | 1 (4.8) | 8 (6.5) | 1 (2.9) | 1 (12.5) | 0 |
| CK > ULN × 5 | 1 (0.5) | 0 | 1 (0.8) | 0 | 0 | 0 |
| sCr > Baseline × 2.0 | 0 | 0 | 0 | 0 | 0 | 0 |
Data are presented as the number of patients (%). Baseline eGFR categories are as follows: G1, eGFR ≥90 mL/min/1.73 m2; G2, eGFR ≥60 and <90 mL/min/1.73 m2; G3a–G3b, eGFR ≥30 and <60 mL/min/1.73 m2; G4–G5, eGFR <30 mL/min/1.73 m2. eGFR, estimated glomerular filtration rate; AE, adverse event; ADR, adverse drug reaction; CK, creatine kinase; ULN, upper limit of normal; sCr, serum creatinine.