Table 2.
Treatment-emergent adverse events, discontinuation, and deaths at 18 months from randomization (safety population)
| KRd (n = 392) | Rd (n = 389) | |
|---|---|---|
| Patients with any-grade AE, n (%) | 379 (96.7) | 372 (95.6) |
| Grade ≥ 3 AE, n (%) | 315 (80.4) | 293 (75.3) |
| Serious AEs, n (%) | 211 (53.8) | 180 (46.3) |
| AE leading to treatment discontinuation, n (%) | 83 (21.2) | 81 (20.8) |
| AE leading to death, n (%) | 25 (6.4) | 29 (7.5) |
| Any-grade AEs of interest, n (%) | ||
| Anemia | 157 (40.1) | 147 (37.8) |
| Thrombocytopenia | 107 (27.3) | 84 (21.6) |
| Neutropenia | 137 (34.9) | 126 (32.4) |
| Hypertension | 51 (13.0) | 23 (5.9) |
| Dyspnea (HLT) | 82 (20.9) | 67 (17.2) |
| Peripheral neuropathy (SMQN) | 59 (15.1) | 55 (14.1) |
| Cardiac failure (SMQN) | 23 (5.9) | 13 (3.3) |
| Acute renal failure (SMQN) | 26 (6.6) | 24 (6.2) |
| Grade ≥ 3 AEs of interest, n (%) | ||
| Anemia | 69 (17.6) | 65 (16.7) |
| Thrombocytopenia | 63 (16.1) | 47 (12.1) |
| Neutropenia | 111 (28.3) | 99 (25.4) |
| Hypertension | 16 (4.1) | 5 (1.3) |
| Dyspnea | 10 (2.6) | 6 (1.5) |
| Peripheral neuropathy (SMQN) | 9 (2.3) | 9 (2.3) |
| Cardiac failure (SMQN) | 14 (3.6) | 5 (1.3) |
| Acute renal failure (SMQN) | 9 (2.3) | 12 (3.1) |
AE adverse event, HLT high-level term, KRd carfilzomib, lenalidomide, and dexamethasone, Rd lenalidomide and dexamethasone, SMQN standardized Medical Dictionary for Regulatory Activities query, narrow scope