Table 5. Adverse events, treatment discontinuations and deaths (safety population).
| Preferred term |
High risk |
Standard risk |
Unknown/missing |
|||
|---|---|---|---|---|---|---|
| Kd (n=97) | Vd (n=111) | Kd (n=283) | Vd (n=287) | Kd (n=83) | Vd (n=58) | |
| Treatment duration, median weeks (range) | 30.3 (1.0–93.1) | 22.0 (1.0–85.0) | 40.9 (2.0–108.1) | 28.0 (1.0–106.1) | 36.9 (1.0–104.0) | 21.3 (1.0–70.0) |
| Grade ⩾3 treatment-emergent AE, n (%) | 68 (70.1) | 70 (63.1) | 209 (73.9) | 196 (68.3) | 62 (74.7) | 39 (67.2) |
| Patients with at least one treatment-emergent AE leading to study treatment discontinuation, n (%) | 18 (18.6) | 22 (19.8) | 56 (19.8) | 62 (21.6) | 18 (21.7) | 11 (19.0) |
| Deaths within 30 days of last dose of any study drug, n (%)a | 8 (8.2) | 5 (4.4) | 9 (3.2) | 14 (4.8) | 5 (6.0) | 2 (3.3) |
| Hematologic grade ⩾3 AEs,b n (%) | ||||||
| Anemia | 14 (14.4) | 14 (12.6) | 44 (15.5) | 23 (8.0) | 9 (10.8) | 8 (13.8) |
| Thrombocytopenia | 7 (7.2) | 14 (12.6) | 23 (8.1) | 21 (7.3) | 9 (10.8) | 8 (13.8) |
| Decreased platelet count | 2 (2.1) | 6 (5.4) | 11 (3.9) | 16 (5.6) | 4 (4.8) | 2 (3.4) |
| Decreased lymphocyte count | 3 (3.1) | 2 (1.8) | 21 (7.4) | 6 (2.1) | 2 (2.4) | 0 |
| Lymphopenia | 5 (5.2) | 1 (0.9) | 10 (3.5) | 6 (2.1) | 5 (6.0) | 5 (8.6) |
| Nonhematologic grade ⩾3 AEs,b n (%) | ||||||
| Pneumonia | 8 (8.2) | 10 (9.0) | 19 (6.7) | 18 (6.3) | 5 (6.0) | 8 (13.8) |
| Fatigue | 5 (5.2) | 7 (6.3) | 18 (6.4) | 20 (7.0) | 2 (2.4) | 5 (8.6) |
| Asthenia | 4 (4.1) | 3 (2.7) | 11 (3.9) | 8 (2.8) | 1 (1.2) | 3 (5.2) |
| Hypertension | 6 (6.2) | 4 (3.6) | 30 (10.6) | 8 (2.8) | 5 (6.0) | 0 |
| Diarrhea | 4 (4.1) | 9 (8.1) | 10 (3.5) | 23 (8.0) | 2 (2.4) | 2 (3.4) |
| Peripheral neuropathy | 1 (1.0) | 4 (3.6) | 4 (1.4) | 20 (7.0) | 1 (1.2) | 0 |
| Dyspnea | 5 (5.2) | 1 (0.9) | 16 (5.7) | 6 (2.1) | 4 (4.8) | 3 (5.2) |
| Back pain | 1 (1.0) | 0 | 4 (1.4) | 9 (3.1) | 3 (3.6) | 3 (5.2) |
| Bone pain | 1 (1.0) | 0 | 4 (1.4) | 4 (1.4) | 5 (6.0) | 2 (3.4) |
| Syncope | 0 | 1 (0.9) | 0 | 8 (2.8) | 0 | 3 (5.2) |
Abbreviations: AE, adverse event; Kd, carfilzomib and dexamethasone; Vd, bortezomib and dexamethasone.
a
Percentage based on the intention-to-treat population of 97 (Kd) and 113 (Vd) high-risk patients; 284 (Kd) and 291 (Vd) standard-risk patients; and 83 (Kd) and 61 (Vd) unknown/missing cytogenetics patients.
b
Grade ⩾3 adverse events reported in ⩾5% of patients in any subgroup.