Table 3. Safety summary of the study participant.
| Side effects, n (%) | All patients (N = 492) | Age 65–74 years (N = 278) | Age ≥ 75 (N = 214) | P value |
|---|---|---|---|---|
| Fatigue | 43 (8.7) | 27 (9.7) | 16 (7.5) | 0.478 |
| Nausea | 13 (2.6) | 7 (2.5) | 6 (2.8) | 1.000 |
| Pruritus | 66 (13.4) | 46 (16.5) | 20 (9.3) | 0.029 |
| Dizziness | 56 (11.4) | 30 (10.8) | 26 (12.1) | 0.744 |
| Laboratory adverse event | All patients (N = 490) | Age 65–74 years (N = 276)a | Age ≥ 75 (N = 214) | P value |
| Anemiab | 0.041 | |||
| G1 | 418 (85.3) | 244 (88.4) | 174 (81.3) | |
| G2 | 57 (11.6) | 23 (8.3) | 34 (15.9) | |
| G3 | 15 (3.1) | 9 (3.3) | 6 (2.8) | |
| Bilirubin | 0.535 | |||
| 1.5–3 × elevation | 38 (7.8) | 23 (8.3) | 15 (7) | |
| ≥3 × elevation | 13 (2.7) | 9 (3.3) | 4 (1.9) | |
| AST | 0.444 | |||
| 3–5 × elevation | 12 (2.4) | 5 (1.8) | 7 (3.3) | |
| ≥5 × elevation | 4 (0.8) | 3 (1.1) | 1 (0.5) | |
| ALT | 0.439 | |||
| 3–5 × elevation | 12 (2.4) | 5 (1.8) | 7 (3.3) | |
| ≥5 × elevation | 5 (1) | 2 (0.7) | 3 (1.4) |
Notes.
a
Two patients who withdrew before ETVR were not included for analysis of adverse events.
b
The anemia grade was in accordance with the Common Terminology Criteria for Adverse Events version 5.0.