Table 4.
Safety outcomes by renal impairment subgroup
| N (%) | ||||||
|---|---|---|---|---|---|---|
| CrCL, mL/min | ||||||
| ≥15 to <50 | 50 to <80 | ≥80 | ||||
| Kd56 (n = 85) | Vd (n = 97) | Kd56 (n = 186) | Vd (n = 174) | Kd56 (n = 192) | Vd (n = 185) | |
| Median duration of treatment, wk | 36 | 21 | 50 | 27 | 52 | 31 |
| IQR | 18-68 | 12-34 | 25-87 | 15-45 | 26-103 | 17-60 |
| Median n of cycles received | 9 | 7 | 12 | 8 | 13 | 10 |
| IQR | 4-17 | 4-11 | 6-21 | 5-13 | 7-25 | 6-19 |
| Patients with AEs leading to carfilzomib or bortezomib discontinuation | 27 (31.8) | 23 (23.7) | 47 (25.3) | 41 (23.6) | 46 (24.0) | 38 (20.5) |
| Treatment-emergent grade ≥3 AEs of interest* | ||||||
| Hypertension | 12 (14.1) | 3 (3.1) | 27 (14.5) | 7 (4.0) | 30 (15.6) | 5 (2.7) |
| Peripheral neuropathy | 0 | 4 (4.1) | 5 (2.7) | 16 (9.2) | 1 (0.5) | 8 (4.3) |
| Dyspnea | 8 (9.4) | 2 (2.1) | 12 (6.5) | 2 (1.1) | 9 (4.7) | 6 (3.2) |
| Cardiac failure | 4 (4.7) | 0 | 7 (3.8) | 1 (0.6) | 3 (1.6) | 2 (1.1) |
| Acute kidney injury | 3 (3.5) | 2 (2.1) | 4 (2.2) | 2 (1.1) | 5 (2.6) | 3 (1.6) |
| Grade ≥2 peripheral neuropathy* | 0 | 14 (14.4) | 13 (7.0) | 36 (20.7) | 5 (2.6) | 34 (18.4) |
AEs were not adjusted for exposure.
IQR, interquartile range.
*
Preferred term.